Surgical Procedures for Chronic : How to Perform Them, When Not to Perform Them and What to Do If They Don’t Work (Didactic)

PROGRAM CHAIR Michael Hibner, MD

Fred M. Howard, MD Georgine M. Lamvu, MD

Sponsored by AAGL Advancing Minimally Invasive Gynecology Worldwide

Professional Education Information

Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology.

Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ...... 1

Disclosure ...... 3

Diagnosing Pelvic Pain G.M. Lamvu ...... 5

The Role of in Treatment of Pelvic Pain F.M. Howard ...... 12

What if Fails to Cure Pain? M. Hibner ...... 26

Evidence for Surgical Intervention in Patients with Pelvic Pain G.M. Lamvu ...... 36

What if Surgery Causes Pain? M. Hibner ...... 43

Surgical Treatment of G.M. Lamvu ...... 53

Treatment of Less Known Conditions Causing Pelvic Pain M. Hibner ...... 58

CPP as We Understand It Today F.M. Howard ...... 71

Cultural and Linguistics Competency ...... 82

PG 112 Surgical Procedures for Chronic Pelvic Pain: How to Perform Them, When Not to Perform Them and What to Do If They Don’t Work (Didactic)

Michael Hibner, Chair Faculty: Fred M. Howard, Georgine M. Lamvu

Course Description

This course will help gynecologists advance their knowledge and skills in treatment of common and less common conditions causing pelvic pain. This will be accomplished by review of current evidence for effectiveness of surgical intervention in patients with chronic pelvic pain. The role of laparoscopy in diagnosing pathology as well as its usefulness in treatment of disorders causing pelvic pain will be discussed. Current concepts in surgical treatment of endometriosis will be presented. Less known or less common conditions such as painful bladder syndrome, pelvic floor tension myalgia, pelvic congestion syndrome, adhesions and pelvic nerve entrapment syndrome will also be discussed. Finally it will offer treatment choices in cases when surgery fails to relieve pain and when surgery produces pain. This is especially important amidst growing concerns about the risks of procedures utilizing surgical mesh.

Course Objectives

At the conclusion of this course, the participant will be able to: 1) Summarize key components of the diagnostic process in patients with CPP; 2) discuss evidence for performing surgery to treat pelvic pain; 3) describe the role of laparoscopy in diagnosis and treatment of CPP; 4) apply proper surgical treatment of endometriosis in patients with CPP; 5) describe treatment in patients in whom surgery fails to relieve pain; and 6) identify conditions which may cause pain after pelvic surgery.

Course Outline

1:30 Welcome, Introductions and Course Overview M. Hibner

1:35 Diagnosing Pelvic Pain G.M. Lamvu

2:00 The Role of Laparoscopy in Treatment of Pelvic Pain F.M. Howard

2:25 What if Surgery Fails to Cure Pain? M. Hibner

2:50 Evidence for Surgical Intervention in Patients with Pelvic Pain G.M. Lamvu

3:15 Questions & Answers All Faculty

3:25 Break

3:40 What if Surgery Causes Pain? M. Hibner

4:05 Surgical Treatment of Endometriosis G.M. Lamvu

1 4:30 Treatment of Less Known Conditions Causing Pelvic Pain M. Hibner

4:55 CPP as We Understand It Today F.M. Howard

5:20 Questions & Answers All Faculty

5:30 Course Evaluation

2 PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Jonathan Solnik Other: Lecturer - Olympus, Lecturer - Karl Storz Endoscopy-America

SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical Other: Royalties - CooperSurgical Linda Bradley Grants/Research Support: Elsevier Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm Keith Isaacson Consultant: Karl Storz Endoscopy Rosanne M. Kho Other: Honorarium - Ethicon Endo-Surgery C.Y. Liu* Javier Magrina* Ceana H. Nezhat Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy-America Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology William H. Parker Grants/Research Support: Ethicon Women's Health & Urology Consultant: Ethicon Women's Health & Urology Craig J. Sobolewski Consultant: Covidien, CareFusion, TransEnterix Stock Shareholder: TransEnterix Speaker's Bureau: Covidien, Abbott Laboratories Other: Proctor - Intuitve Surgical

FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Michael Hibner* Fred M. Howard Consultant: Ethicon Women's Health & Urology Speaker's Bureau: Abbott Laboratories Georgine M. Lamvu* Frank F. Tu Consultant: Ethicon Endo-Surgery

3

Asterisk (*) denotes no financial relationships to disclose.

4 Disclaimer DIAGNOSING PELVIC PAIN DISORDERS • I have no financial relationships to disclose.

Georgine Lamvu, MD, MPH Director of MIS and Advanced Gynecology Fellowship Medical Director of Gynecology Florida Hospital Orlando

Lamvu, AAGL 2012 1 Lamvu, AAGL 2012 2

2012 IOM Report Objectives Prevalence and Costs of Chronic • Review epidemiology and basic physiology of Pain Disorders chronic pelvic pain • 116 million adults affected by chronic pain • Review the basic requirements of the initial disorders annually in the U.S. clinical evaluation in women with chronic • Estimated costs $560‐635 billion annually pelvic pain (poor health and low productivity) • Review recommendations for evaluation • Medicare bears ¼ of medical expenditures for • Important selected references listed on the pain, in 2008 it was $65.3 billion last slide • Pain is a universal experience

Lamvu, AAGL 2012 3 Lamvu, AAGL 2012 4

Summary of US Prevalence Dysmenorrhea: Cyclical Pelvic Pain

• 25 million women with chronic pelvic pain, prevalence ranges from 4‐49% in various populations • 14 million women with vaginal or vulvar pain • 25‐43% of the world’s female population has been affected by chronic pelvic pain 106 studies, 125,249 women Prevalence: 16‐81%; 8.7% (Bulgaria) to 97% (Finland)

P Latthe, M Latthe, Say, et al. BMC Public Health 2006 Lamvu, AAGL 2012 5 Lamvu, AAGL 2012 6

5 Noncyclical Pelvic Pain

18 studies, 299,740 women 54 Studies, 35,973 women Prevalence: 2.1%‐24%; 5.2% (India) to 43.2% (Thailand) Prevalence: 8%‐21%; 1.1% (Sweeden) to 45% (US)

P Latthe, M Latthe, Say, et al. BMC Public Health 2006 P Latthe, M Latthe, Say, et al. BMC Public Health 2006

Lamvu, AAGL 2012 7 Lamvu, AAGL 2012 8

Main Objective Today

To clarify and simplify your understanding of chronic pelvic pain which is often viewed by general medical providers as a difficult, puzzling and frustrating disorder with few treatment options. Epidemiology of Chronic Pelvic Pain

LESS THAN 5% OF PATIENTS WITH CHRONIC PAIN ARE SEEN BY A PAIN SPECIALIST

Lamvu, AAGL 2012 9 Lamvu, AAGL 2012 10

The Literature Supports Our Clinical Observations PRICE J, et. al. BJOG 2006;113:446‐52. How Do We Improve? SELFE SA,et al. Pain 1998;77:215‐25. GRACE VM. Health Care Women Int 1995;16:509‐19  Most women with CPP have negative perceptions of their • Negative perceptions interactions with providers… especially gynecologists • Patient care  Women often feel like they  Are not receiving personalized care • Pain relief  Are not understood or taken seriously • Quality of life  Often dismissed without reassurance or explanation for their pain  CPP patients have difficulty understanding and accepting normal test results  CPP patient often express disappointment with the overall quality of the consultation Lamvu, AAGL 2012 11 Lamvu, AAGL 2012 12

6 Chronic Pain is Not The Same as Acute Pain

A FEW CHRONIC (PELVIC) PAIN Acute Pain Chronic Pain PRINCIPLES TO REMEMBER  Symptom of injury or  Remote onset and may disease change in character and severity over time  Well defined onset, recent  Unpredictable duration  Expected to end in days or  No apparent biologic weeks function That are supported by research  Essential biologic warning  Progressive or persistent function  May be associated diseases that exacerbate or precipitate manifestations of chronic pain

Lamvu, AAGL 2012 13 Lamvu, AAGL 2012 14

Pelvic Neuro-anatomy

Depression • Pelvic organs share neural pathways – The spinal cord innervates several organs Anxiety Catastrophizing Frustration – Several organs Expectations simultaneously send Anger input into the spinal cord

Lamvu, AAGL 2012 15 Lamvu, AAGL 2012 16

Facilitation Inhibition Substance P Norepinephrine BRAIN Glutamate Opioids Measuring Levels of Pain Serotonin GABA Neurotensin Cannabinoids Nerve growth factor Adenosine • Uni‐dimensional scales such as the Visual CCK Analogue Scale (VAS) are not enough to SPINAL capture many important aspects of pain such Bowel CORD as: Bla dder – Multi‐organ co‐morbidity – Impairment of quality of life and important PERIPHERAL functions such as sexual function NEURON – Impairment of poor coping and stress associated with chronic pain – Changes in function in response to treatment Neural cross‐talk in the pelvis Lamvu, AAGL 2012 17 Lamvu, AAGL 2012 18

7 Current Definition of Pain The 1,2,3 of the Initial Evaluation

1. Establish pattern of chronicity IASP definition: an unpleasant sensory and emotional experience associated 2. Determine how many organs are involved with actual or potential damage or 3. Physical exam to include the three M’s described in terms of such damage. • Mood: psychological and quality of life • Musculoskeletal exam (internal/external) Pain is both a physiologic process composed of impulse transmission • Mucosal exam along neural pathways, involving the release of neurotransmitters , and subjective and emotional experience.

Lamvu, AAGL 2012Slide courtesySlide courtesy of of Anne Anne Marie Marie Fras, Fras, MD 19MD Lamvu, AAGL 2012 20

Establish a Pattern Of Chronicity Establish How Many Organs Are • Use open‐ended questions Involved • Timing • Onset • Associated gastrointestinal, urinary and • Duration musculoskeletal symptoms • Previous treatments tried • Alleviating or exacerbating factors • Allow patient to express how pain effects • Daily function • Quality of life Gastrointestinal • Allow patient to identify what is most distressing Urologic The quality of the initial gynecological consultation is Reproductive associated with success of follow up and recovery Musculoskeletal

Selfe et al. Factors influencing outcome in consultations for chronic pelvic pain. J Zondervan KT. Br J Obstet Gynaecol. 1999;106:1156‐1161. Womens Health, 7: 1041‐8. 1998. Howard FM. Obstet Gynecol. 2003:101:594‐611.

Lamvu, AAGL 2012 21 Lamvu, AAGL 2012 22

Pelvic Pain Examination Physical Examination

Muscle Abdominal Pelvic • Sequential examination, you may not be able Appearance Skeletal to do everything in one visit!

• Don’t get stuck on one diagnosis Walking Sensory External Standing Contraction Internal Mood – It may change Strength Relaxation single digit Affect – Multiple organ systems may be involved Reflexes Insertion points speculum Sensory Scars bimanual • Remember your neurobiology and think Motor Trigger points rectovaginal central mechanisms •Identify location that REPLICATES pain •Pain intensity and affective response •Referral pattern Lamvu, AAGL 2012 23 Lamvu, AAGL 2012 24

8 Musculoskeletal Evaluation Musculoskeletal Examination •Identify asymmetry and pain associated with Low Back Pain movement of the – PSIS, ASIS • Palpate paraspinal structures – Iliac Crest, – Pubic Symphysis • With sciatica symptoms: – Greater Trochanter Lasegue’s test – (+) test suggests L4–5 or L5–S1 disc herniation

Vroomen JC, et al, J Neurol. 1999 Slide courtesy of Frank Tu, MD

Slide courtesy of Frank Tu, MD. Lamvu, AAGL 2012 25 Lamvu, AAGL 2012 26

Abdominal Examination Vaginal Examination Look First! External Survey •Evaluate abdominal wall for tender muscular points (trigger points, myofascial pain) Carnett’s test • Vulvar or vestibular skin •Assess both deep and superficial (brush) lesions pain sensitivity especially around scars – ulcerations, fissures •While the patient performs a “crunch” pppalpate the rectus and obliques • Swelling or redness •To distinguish visceral/ intr‐aperitoneal • Vestibular hypersensitivity pain from regional somatic pain with Q‐ti touch • deep pelvic pain improves when the • Atrophic changes muscles are contracted • Urethral meatus •Muscular pain worsens when the muscles are contracted • Pelvic organ prolapse

Slide courtesy of Frank Tu, MD Lamvu, AAGL 2012 27 Lamvu, AAGL 2012 28

Vaginal Examination: Vulvar Pain: Sensory Innervation Palpate Second: Internal Single of the Perineum Digit •Voluntary contraction, strength, relaxation and pain of muscles: •Introitus •Levatorplate • Obturator •Pain of • Bladder • •Urethral • Ischeal tuberosity and alcock’s canal

Lamvu, AAGL 2012 29 Lamvu, AAGL 2012 30

9 Internal Examination Internal Bimanual and Speculum Examination Rectovaginal Examination

• Vaginal walls • Uterus – Size • Vaginal fornices • – Location – or vaginal cuff • Uterosacrals – Mobility • Cervix – Tenderness • Posterior cul‐de‐ • Vaginal discharge – Nodularity – pH sac – Masses – Wet mount • Rectovaginal vault – STI cultures

Lamvu, AAGL 2012 31 Lamvu, AAGL 2012 32

Integrate Your Examination Findings Therapies for CPP Disorders Into a Diagnosis and Treatment Plan

Myofascial syndrome Physical therapy Musculoskeletal Trigger points Muscle relaxants Somatic Loss of muscle Trigger point function injections

Urinary Dietary c hanges Organ Specific Gastrointestinal Anti‐spasmotics Visceral Reproductive Cycle suppression

Depression Antidepressants Anxiety Anxiolytics Mood Poor coping Cognitive behavioral Sexual dysfunction therapy

Lamvu, AAGL 2012 33 Lamvu 2011 34

Surgical Summary Alternative Complimentary Hormonal Therapy • Take more time with the history and physical than with anything else

Physical Neuropathic • Try to distinguish whether multiple organs are Therapy Individualized Blocks involved Multidisciplinary Therapy • Use single digit exam over gllblobal bblimanual to optimize specificity Cognitive Analgesics Behavioral • Always consider primary or secondary Therapy musculoskeletal causes • Always consider the psychosocial and sexual Antidepressants Anticonvulsants environment

Lamvu 2011 35 Lamvu, AAGL 2012 36

10 References • P Latthe, M Latthe, Say, et al. BMC Public Health 2006 • PRICE J, et. al. BJOG 2006;113:446‐52. • SELFE SA,et al. Pain 1998;77:215‐25. • GRACE VM. Health Care Women Int 1995;16:509‐19 • Selfe et al. Factors influencing outcome in consultations for chronic pelvic pain. J Womens Health, 7: 1041‐8. 1998. [email protected] • Zondervan KT. Br J Obstet Gynaecol. 1999;106:1156‐ 1161. THANK YOU • Howard FM. Obstet Gynecol. 2003:101:594‐611. • Vroomen JC, et al, J Neurol. 1999 • Institute of Medicine: Relieving Pain in America. 2012

Lamvu, AAGL 2012 37 Lamvu, AAGL 2012 38

11 DISCLOSURE The Role of Laparoscopy in the Treatment of Pelvic Pain Consultant: Ethicon Women's Health & Urology Fred M. Howard, MS, MD Speaker's Bureau: Abbott Laboratories Professor Emeritus of Obstetrics‐Gynecology UiUniversi ty of RhRochester School of Medicine & Dentistry Rochester, New York [email protected]

OBJECTIVES Traditional Role of Laparoscopy in CPP

• Identify the disorders that may require laparoscopy • Routine part of the evaluation of chronic pelvic pain for diagnosis • Abnormal exam correlates with abnormal • List the important disorders in CPP that do not laparoscopic findings in 70‐90% of cases require laparoscopy & have negative laparoscopic • Normal exam in >1/2 with abnormal laparoscopic findings findings • Formulate the appropriate role for laparoscopy in – Laparoscopy may allow the detection of potentially women with CPP treatable pathology not detected by exam

Laparoscopy in Women with Prior Treatment Laparoscopy in Women with Prior Treatment

• Multidisciplinary evaluation & treatment “is more 80 70 likely to result in a reduction of pelvic pain than is 60 the standard form of care.” 50 % with • “If a carefully taken history and an expert pelvic 40 Improvement GLGyn Laparoscopy 30 Multidisciplinary examination are negative, it is doubtful whether 20 invasive measures such as laparoscopy have any 10 additional information to offer.” 0 General Daily Assoc Sxs McGill Activities

Peters AAW, et al. Obstet Gynecol 1991;77:740 Peters AAW, et al. Obstet Gynecol 1991;77:740

12 Evidence Based Evaluation of Diagnoses Associated with CPP Level A Evidence Diagnoses Reproductive Tract Diagnoses • Endometriosis • Gynecologic malignancies • Ovarian retention syndrome • Ovarian remnant syndrome • (Pelvic congestion syndrome) • Pelvic inflammatory disease • Tuberculous salpingitis

Level A Evidence Diagnoses Level A Evidence Diagnoses Reproductive Tract Diagnoses Urinary Tract Diagnoses • Endometriosis • Bladder malignancy • Gynecologic malignancies • Interstitial cystitis • Ovarian retention syndrome • Radiation cystitis • Ovarian remnant syndrome • (Pelvic congestion syndrome) • Urethral syndrome • Pelvic inflammatory disease • Tuberculous salpingitis

Level A Evidence Diagnoses Level A Evidence Diagnoses

Urinary Tract Diagnoses Gastrointestinal Tract Diagnoses • Bladder malignancy • Carcinoma of the colon • Interstitial cystitis • Constipation • Radiation cystitis • Inflammatory bowel disease • Urethral syndrome • Irritable bowel syndrome

13 Level A Evidence Diagnoses Level A Evidence Diagnoses

Gastrointestinal Tract Diagnoses Musculoskeletal System Diagnoses • Abdominal wall myofascial pain (trigger points) • Carcinoma of the colon • Abdominal cutaneous nerve entrapment in surgical scar • Chronic coccygeal or back pain • Constipation • Faulty or poor posture • Inflammatory bowel disease • Fibromyalgia • Neuralgia of iliohypogastric, ilioinguinal, and/or genitofemoral • Irritable bowel syndrome nerves • Pelvic floor myalgia (levator ani or piriformis syndrome) • Peripartum pelvic pain syndrome

Level A Evidence Diagnoses Level A Evidence Diagnoses

Musculoskeletal System Diagnoses Psychological Diagnoses • Abdominal wall myofascial pain (trigger points) • Abdominal cutaneous nerve entrapment in surgical scar • Depression • Chronic coccygeal or back pain • Faulty or poor posture • Catatrophizing • Fibromyalgia • Somatization disorder • Neuralgia of iliohypogastric, ilioinguinal, and/or genitofemoral nerves • Pelvic floor myalgia (levator ani or piriformis syndrome) • Peripartum pelvic pain syndrome

Level A Evidence Diagnoses Level B Evidence Diagnoses

Psychological Diagnoses Reproductive Tract Diagnoses • Depression • Adhesions • Catatrophizing • Benign cystic mesothelioma • Somatization disorder • Leiomyomata • Postoperative peritoneal cysts

14 Level B Evidence Diagnoses Level B Evidence Diagnoses

Reproductive Tract Diagnoses Urinary Tract Diagnoses • Adhesions • Adhesions • Benign cystic mesothelioma • Uninhibited bladder contractions (detrusor • Leiomyomata di)dyssynergia) • Postoperative peritoneal cysts • Urethral diverticulum

Level B Evidence Diagnoses Level B Evidence Diagnoses

Urinary Tract Diagnoses Gastrointestinal Tract Diagnoses • Adhesions • Adhesions • Uninhibited bladder contractions (detrusor • Celiac disease di)dyssynergia) • Porphyria • Urethral diverticulum

Level B Evidence Diagnoses Level B Evidence Diagnoses

Gastrointestinal Tract Diagnoses Musculoskeletal System Diagnoses • Adhesions • Herniated nucleus pulposus • Celiac disease • Low back pain • Porphyria • Neurologic dysfunction • Neoplasia of spinal cord or sacral nerve • Shingles

15 Level B Evidence Diagnoses Level B Evidence Diagnoses

Musculoskeletal System Diagnoses Psychological Diagnoses • Herniated nucleus pulposus • Sleep disturbances • Low back pain • Neurologic dysfunction • Neoplasia of spinal cord or sacral nerve • Shingles

Level B Evidence Diagnoses Level C Evidence Diagnoses

Psychological Diagnoses Reproductive Tract Diagnoses • Adenomyosis • Sleep disturbances • Atypical dysmenorrhea or ovulatory pain • Adnexal cysts (nonendometriotic) • Cervical stenosis • Chronic ectopic ppgregnanc y • Chronic endometritis • Endometrial or cervical polyps • Endosalpingiosis • Intrauterine contraceptive device • Ovarian ovulatory pain • Residual accessory • Symptomatic pelvic relaxation (genital prolapse)

Level C Evidence Diagnoses Level C Evidence Diagnoses

Reproductive Tract Diagnoses • Adenomyosis Urinary Tract Diagnoses • Atypical dysmenorrhea or ovulatory pain • Adnexal cysts (nonendometriotic) • Chronic urinary tract infection • Cervical stenosis • Chronic ectopic ppgregnanc y • Recurrent, acute urethritis • Chronic endometritis • Endometrial or cervical polyps • Recurrent, acute cystitis • Endosalpingiosis • Intrauterine contraceptive device • Stone/urolithiasis • Ovarian ovulatory pain • Residual accessory ovary • • Symptomatic pelvic relaxation (genital prolapse) Urethral caruncle

16 Level C Evidence Diagnoses Level C Evidence Diagnoses

Urinary Tract Diagnoses Gastrointestinal Tract Diagnoses • Chronic urinary tract infection • Abdominal epilepsy • Recurrent, acute urethritis • Abdominal migraine • Colitis • Recurrent, acute cystitis • Chronic intermittent bowel obstruction • Stone/urolithiasis • Diverticular disease • Urethral caruncle • Familial Mediterranean fever

Level C Evidence Diagnoses Level C Evidence Diagnoses

Gastrointestinal Tract Diagnoses Musculoskeletal System Diagnoses • Abdominal epilepsy • Compression of lumbar vertebrae • Abdominal migraine • Degenerative joint disease • • Colitis Hernias: ventral, inguinal, femoral, spigelian • Muscular strains and sprains • Chronic intermittent bowel obstruction • Rectus tendon strain/Rectus abdominis pain • Diverticular disease syndrome • Familial Mediterranean fever • Spondylosis

Level C Evidence Diagnoses Level C Evidence Diagnoses

Musculoskeletal System Diagnoses Psychological Diagnoses • Compression of lumbar vertebrae • Bipolar personality disorders • Degenerative joint disease • Hernias: ventral, inguinal, femoral, spigelian • Muscular strains and sprains • Rectus tendon strain/Rectus abdominis pain syndrome • Spondylosis

17 Level C Evidence Diagnoses Diagnoses “Requiring” Diagnostic Laparoscopy

1. Endometriosis 7. Postoperative peritoneal Psychological Diagnoses 2. Ovarian remnant cysts syndrome 8. Adnexal cysts • Bipolar personality disorders 3. Pelvic inflammatory (nonendometriotic) disease 9. Chronic ectopic pregnancy 4. Tuberculous salpingitis 10. Endosalpingiosis 5. Adhesions 11. Residual accessory ovary 6. Benign cystic 12. Hernias: ventral, inguinal, mesothelioma femoral, spigelian

Interim Points Interim Points

• Abandon the idea that laparoscopy is essential • Laparoscopy often has a therapeutic role in in the evaluation of CPP chronic pelvic pain • Abandon the idea that laparoscopy is the • Preferred approach to surgical treatment of penultimate diagnostic test in CPP many of the disorders amenable to operative – Negative findings do not mean there is no organic treatment diagnosis

Diagnoses “Requiring” Diagnostic Laparoscopy Diagnosis of Endometriosis 1. Endometriosis 7. Postoperative peritoneal 2. Ovarian remnant cysts • syndrome 8. Adnexal cysts Histologic diagnosis, not 3. Pelvic inflammatory (nonendometriotic) laparoscopic diagnosis disease 9. Chronic ectopic pregnancy • Ectopic endometrial 4. Tuberculous salpingitis 10. Endosalpingiosis 5. Adhesions 11. Residual accessory ovary glands and stroma must 6. Benign cystic 12. Hernias: ventral, inguinal, be present mesothelioma femoral, spigelian – Requires a tissue specimen

18 Visual Diagnosis VISUAL DIAGNOSIS

Description of Lesion Confirmation of Diagnosis Black 90% • Positive predictive value = 45% Brown 78% White 76% • Negative perdictive value = 99% Red 67% Clear papules 67% • Sensitivity = 97% Glandular 67% Peritoneal defects 41% • Specificity = 77% Superficial yellow-brown 40% Adhesions (ovarian) 40% Carbon 17% Adhesions (non-ovarian) 12% Cribriform peritoneal defects 9%

Walter et al. Am J Obstet Gynecol 2001;184:1407

Not a Visual Diagnosis Not a Visual Diagnosis

Not a Clinical Diagnosis Clinical Diagnosis Clinical vs Histological Diagnosis • Of 95 women clinically diagnosed with Negative Positive Total endometriosis, 81% had confirmations at the Histology Histology time of laparoscopy Endometriosis – Suggests that laparoscopy is not necessary before starting medical 134 (76%) 43 (24%) 177 not clinically treatment diagnosed Endometriosis 72 126 (64%) 198 clinically diagnosed Total 206 169 375

Ling FW. Obstet & Gynecol 1999;93:51-8 Howard FM. Unpublished data

19 Not a Clinical Diagnosis NOT A VISUAL DIAGNOSIS Clinical vs Histological Diagnosis NOT A CLINICAL DIAGNOSIS

Negative Positive Total • Clinical diagnosis Histology Histology – Positive predictive value = 64% Endometriosis 134 (76%) 43 177 – Negative predictive value = 76% not clinically diagnosed • Visua l lilaparoscopic diagnos is Endometriosis 72 126 (64%) 198 – Positive predictive value = 45% clinically diagnosed – Negative predictive value = 99% Total 206 169 375

Howard FM. Unpublished data Howard FM. Unpublished data Walter et al. Am J Obstet Gynecol 2001;184:1407

Laparoscopy for Endometriosis Diagnoses “Requiring” Diagnostic Laparoscopy

• Thorough knowledge of the various 1. Endometriosis 7. Postoperative peritoneal 2. Ovarian remnant cysts appearances of endometriosis syndrome 8. Adnexal cysts 3. Pelvic inflammatory (nonendometriotic) • Liberal use of excisional biopsies disease 9. Chronic ectopic pregnancy • Thhhorough evaliluation of t he pellivis 4. Tuberculous salpingitis 10. Endosalpingiosis 5. Adhesions 11. Residual accessory ovary – At least a double‐puncture technique 6. Benign cystic 12. Hernias: ventral, inguinal, – "Near‐contact" laparoscopy mesothelioma femoral, spigelian

Ovarian Remnant Syndrome Ovarian Remnant Syndrome Diagnostic Studies • Pelvic pain or mass due to persistence of ovarian • Vaginal ultrasound shows pelvic mass in 50‐85% of cases fragments unintentionally left in situ during (difficult) – Diagnostic accuracy improved by pretreatment with clomiphene citrate if functional follicles are present • Most commonly described after a previous bilateral • FSH levels – salpingoophorectomy and No hhlormonal replltacement for three weeks or more – Pre‐menopausal FSH levels in 50‐75% • Occurs more commonly than generally thought • GnRH‐a stimulation test – Baseline & 3‐7 day post‐injection levels of

20 Ovarian Remnant Syndrome Ovarian Remnant Syndrome Medical Treatment • Hormonal suppression Ovarian Remnant Ovarian Remnant – Depot‐medroxyprogesterone acetate (150 mg IM each month) – Danazol (600 m g per da y PO ) Endometriosi – Depot‐leuprolide acetate (3.75 mg IM each month) s – Combined estrogen‐progestagen • Radiation treatment (2000‐3000 cGy)

Ureter

Diagnoses “Requiring” Diagnostic Laparoscopy Pelvic Inflammatory Disease 1. Endometriosis 7. Postoperative peritoneal 2. Ovarian remnant cysts syndrome 8. Adnexal cysts 3. Pelvic inflammatory (nonendometriotic) • 30% of women disease 9. Chronic ectopic pregnancy develop CPP after 4. Tuberculous salpingitis 10. Endosalpingiosis 5. Adhesions 11. Residual accessory ovary PID 6. Benign cystic 12. Hernias: ventral, inguinal, mesothelioma femoral, spigelian

Ness RB et al. Am J of Obstet Gynecol 186:929-37, 2002

Diagnoses “Requiring” Diagnostic Laparoscopy Adhesions 1. Endometriosis 7. Postoperative peritoneal 2. Ovarian remnant cysts syndrome 8. Adnexal cysts • Etiology 3. Pelvic inflammatory (nonendometriotic) – PID disease 9. Chronic ectopic pregnancy – Endometriosis 4. Tuberculous salpingitis 10. Endosalpingiosis – Perforated appendix 5. Adhesions 11. Residual accessory ovary 6. Benign cystic 12. Hernias: ventral, inguinal, – Prior surgery mesothelioma femoral, spigelian – Inflammatory bowel disease

21 Adhesions Adhesions

• Physical appearance • Presently the only definitive way to of adhesions are not diagnose adhesions is by surgical specific to the visualization underlying cause • Excision & histology may be important in women with endometriosis

Laparoscopic Treatment of ‐Associated Pelvic Pain Reformed Adhesions

• Observational studies suggest efficacy of 60‐90% Reformed Adhesions • RCT laparoscopic adhesiolysis showed no efficacy at 12 months 100 90 Swank et al. Lancet 2003;361:1247 80 • RCT adhesiolysis by lapyparotomy showed no difference at 11 70 60 months % w i t h 50 Peters AAW, et al. Br J Obstet Gynaecol 1992;99:59 Adhesions 40 • RCT paracolic adhesiolysis showed improvement in pain at 4‐ 30 8 weeks. 20 10 Keltz et al. JSLS 2006: 10; 443‐46 0 Ovarian Laparoscopy Laparotomy

Diamond M, et al. Fertil Steril 1991;55:700-704 Franklin RR, et al. Obstet Gynecol 1995;86:335-340

Laparoscopic Treatment of Diagnoses “Requiring” Diagnostic Laparoscopy Adhesion‐Associated Pelvic Pain 1. Endometriosis 7. Postoperative peritoneal cysts • Prevention of recurrent 2. Ovarian remnant syndrome 8. Adnexal cysts adhesions (nonendometriotic) – 3. Pelvic inflammatory Unnecessary suture material disease 9. Chronic ectopic pregnancy – Residual blood or clots 4. Tuberculous salpingitis 10. Endosalpingiosis – Unnecessary tissue trauma & handling 5. Adhesions 11. Residual accessory ovary • Currently Interceed is only 6. Benign cystic 12. Hernias: ventral, inguinal, product with evidence of mesothelioma femoral, spigelian efficacy that can be used laparoscopically

22 Benign Cystic Mesothelioma Diagnoses “Requiring” Diagnostic Laparoscopy

1. Endometriosis 7. Postoperative peritoneal 2. Ovarian remnant cysts syndrome 8. Adnexal cysts 3. Pelvic inflammatory (nonendometriotic) disease 9. Chronic ectopic pregnancy 4. Tuberculous salpingitis 10. Endosalpingiosis 5. Adhesions 11. Residual accessory ovary 6. Benign cystic 12. Hernias: ventral, inguinal, mesothelioma femoral, spigelian

Postoperative Peritoneal Cyst Diagnoses “Requiring” Diagnostic Laparoscopy

1. Endometriosis 7. Postoperative peritoneal 2. Ovarian remnant cysts syndrome 8. Adnexal cysts 3. Pelvic inflammatory (nonendometriotic) disease 9. Chronic ectopic pregnancy 4. Tuberculous salpingitis 10. Endosalpingiosis 5. Adhesions 11. Residual accessory ovary 6. Benign cystic 12. Hernias: ventral, inguinal, mesothelioma femoral, spigelian

Diagnosis of Ovarian Cysts Laparoscopy & Ovarian Cysts • Presence of ovarian cysts can be diagnosed without • Residual ovary laparoscopy syndrome – Ultrasound – Ovarian retention El‐Minawi A, Howard FM. J Am Assoc Gynecol Laparosc – CT scan 1999 66297:297. – MRI scan • Recurrent functional – Physical examination cysts Stone SC, Swartz WJ. Am J Obstet Gynecol 134:310,1979. • Identification of ovarian cysts may require histology

23 Treatment of Ovarian Cysts Diagnoses “Requiring” Diagnostic Laparoscopy 1. Endometriosis 7. Postoperative peritoneal • Precautions re: 2. Ovarian remnant cysts malignancy syndrome 8. Adnexal cysts 3. Pelvic inflammatory (nonendometriotic) • Complete removal or disease 9. Chronic ectopic pregnancy destruction of cyst wall 4. Tuberculous salpingitis 10. Endosalpingiosis • Histology 5. Adhesions 11. Residual accessory ovary 6. Benign cystic 12. Hernias: ventral, inguinal, mesothelioma femoral, spigelian

Endosalpingiosis Endosalpingiosis

• Ectopic fallopian tubal • Diagnosis glandular epithelium – Usually not recognized – White‐yellow, opaque or misdiagnosed as or translucent, endometriosis punctate, cystic – Important to biopsy lesions • Evidence re: CPP – Observational & limited

Diagnoses “Requiring” Diagnostic Laparoscopy Ventral Umbilical Hernia 1. Endometriosis 7. Postoperative peritoneal 2. Ovarian remnant cysts syndrome 8. Adnexal cysts 3. Pelvic inflammatory (nonendometriotic) disease 9. Chronic ectopic pregnancy 4. Tuberculous salpingitis 10. Endosalpingiosis 5. Adhesions 11. Residual accessory ovary 6. Benign cystic 12. Hernias: ventral, inguinal, mesothelioma femoral, spigelian

24 Laparoscopic Pain Mapping Sciatic Hernia

Non‐CLPM series (65) CLPM series (50) • Endometriosis 38% • Endometriosis 40% • Adhesions 34% • Adhesions 54% • Decreased pain 78% • Decreased pain 44% • Pain‐free 45% • Pain‐free 16%

Howard FM, et al. Obstet Gynecol 2000; 96: 934

THANK YOU REFERENCES

• Peters AAW, et al. Obstet Gynecol 1991;77:740 • Walter et al. Am J Obstet Gynecol 2001;184:1407 Whosoever is spared personal • Ling FW. Obstet & Gynecol 1999;93:51‐8 pain must feel himself called to • Ness RB et al. Am J of Obstet Gynecol 186:929‐37, 2002 help in diminishing the pain of • Diamond M, et al. Fertil Steril 1991;55:700‐704 • Franklin RR, et al. Obstet Gynecol 1995;86:335‐340 others…… • Howard & Sanchez. Obstet Gynecol 2000; 96: 934 • Howard FM. Obstet Gynecol 2003;101:594‐611 Pain is a more terrible lord of • Howard FM. J Am Assoc Gynecol Laparosc 1996; 4:1,85‐94 mankind than even death….. • Swank et al. Lancet 2003;361:1247 • Peters AAW, et al. Br J Obstet Gynaecol 1992;99:59 Dr. Albert Schweitzer • Keltz et al. JSLS 2006: 10; 443‐46 • El‐Minawi A, Howard FM. J Am Assoc Gynecol Laparosc 1999 6:297. • Stone SC, Swartz WJ. Am J Obstet Gynecol 134:310,1979. Albert Schweitzer, 1875 – 1965 •

25 Disclosure

What if surgery fails to • I have no financial relationships to disclose. relieve pain? Michael Hibner, MD, PhD, FACOG, FACS Director, Division of Surgery and Pelvic Pain St. Joseph’s Hospital and Medical Center, Phoenix, Arizona Professor of Obstetrics and Gynecology Creighton University School of Medicine

Objectives Clinical scenario 1

• Identify causes of ongoing pain after 24 years old nulligravida has a history of chronic gynecolog ic surgygery for pelvic p ain pelvic pain, dysmenorrhea, dyspareunia for the past 4 years. Two years ago she had a • Describe diagnostic process in those cases laparoscopy which showed a moderate • State available treatments for ongoing pain endometriosis. Resection helped with pain until after gynecologic surgery for pelvic pain six months ago.

Clinical scenario 1 Clinical scenario 1

Patient states that her pain is getting progressively worse; she is unable to have On laparoscopy you again find moderate intercourse and has to get up to go to the endometriosis involving both uterosacral bathroom several times a night to urinate. On and posterior cul‐de‐sac. You physical examination she has significant successfully remove all the lesions but six weeks tenderness in the pelvis in all areas. You decide after surgery patients pain is unchanged. to proceed with another laparoscopy.

26 Why did the surgery fail? Coexisting conditions

Howard, 2011 Issa et al., 2012 Longstreth et al., 1990

Chung et al., 2005

Endo 50 25 72 86 % % % % • Wrong dia gnosis? 65% 31% 21% • Incomplete diagnosis? PFTM • Wrong treatment? IC IBS

23 % Koziol, 1994 50 %

Coexisting conditions

Howard, 2011

Interstitial cystitis/Painful bladder syndrome

Suprapubic pain related to bladder filling accompanied by other symptoms such as increased daytime and nighttime frequency in the absence of proven urinary tract infection or other obvious pathology INTERSTITIAL CYSTITIS

International Continence Society 2002

27 Interstitial cystitis Interstitial cystitis

UlcerUlcer

ScarringScarring PainPain FrequencyFrequency UrgencyUrgency

Driscoll & Teichman, 2001 Driscoll & Teichman, 2001

NumbersNumbers Natural history

• Prevalence 1‐3% general population (2.7‐6.5% of women) • 5:1 ratio of women to men • 90% stable disease (no progression) • 3‐8 million of patients in US • • 12% of women may have early symptoms 10% progress • Median age 43 years (30‐70) • Some studies show 50% spontaneous • 10 times higher incidence of childhood bladder remission rate problems in IC/PBS patients than controls

15 16 Berry et al., 2011 Koziol et al., 1993

EtiologyEtiology

Neurogenic Autoimmune Bladder inflammation disorder Bladder overdistention trauma

Pelvic floor Bacterial dysfunction Damage to cystitis bladder epithelium Antoproliferative Factor secreted by Bladder fails to epithelial cells repair damage Leak of urine into interstinum

Mast cell C‐fiber activation activation/s Immune ubstance P and and allergic release histamine response release

Chronic neuropathic pain central sensitization Evans, 2002 Butrick, 2003

28 Associated diseases SymptomsSymptoms

• Bladder pain • Urgency (84%) • Irritable bowel syndrome (IBS) • Frequency (92%) • Inflammatory bowel disease (()IBD) • Nocturia • Fibromyalgia • Multiple sexual symptoms • Systemic Lupus Erythematous (SLE) • Dyspareunia (especially worse in certain positions) • Endometriosis • Pain with sexual arousal

Butrick et al., 2010 Butrick et al., 2010

SymptomsSymptoms DiagnosisDiagnosis

• Some patients feel pressure not pain • History: symptoms as above • Pain outside the bladder: , lower back, abdomen • Worsening of symptoms with • Questionnaires • Filling of the bladder (voiding improves symptoms) • PUF (pain/urinary frequency) • Certain foods • Citrus fruits and juices • Used for screening purposes • Tomatoes • Score > 12 highly suggestive of IC/PBS • Cranberry • Pineapple • O’Leary‐Saint • Caffeine • • Alcohol Used for research • Carbonated drinks • Symptoms 12, problem 7 –inclusion in research

Butrick et al., 2010 Butrick et al., 2010

DiagnosisDiagnosis Rule out other causes

Parsons et al., 2002

29 DiagnosisDiagnosis DiagnosisDiagnosis

• Voiding diary • Cystoscopy with hydrodistention (diagnostic) • > 8 voids/day – abnormal • Preformed under anesthesia • Exam • Bladder filled to 80 cm of water • Tenderness with single digit palpation of trigone • Glomerulations • Pinpoint petechial hemorrhages • Laboratory stu dies • Associated with IC/PBS but also seen in other conditions • Urine analysis • 45% of women with any lower urinary tract symptoms without • Rule out UTI IC/PBS have glomerulations • Check for hematuria • 10‐34% with IC/PBS do not have glomerulations ’ • Urine cytology • Hunner s ulcer • Negative cystoscopy does not rule out IC/PBS • Vaginal cultures

Butrick et al., 2010 Butrick et al., 2010

DiagnosisDiagnosis TreatmentTreatment

• Potassium Sensitivity Test (PST) • Avoidance of triggers • First solution 50 ml of NS • Stress reduction • Second solution 40 ml of 0.4M (400 mEq/l) KCl solution • Diet modification • Difference of ≥ 2 above 0 (scale 0‐5) in pain or urgency and • 50‐60% of patients can identify foods causing solution 2 worse than solution 1 symptoms • If pain with solution 2, drain bladder and rate, if not, wait 5 • Eliminate all foods on the IC diet list minutes to rate • Reintroduce 1 food item every other day and look for • Controversial: Parsons –pro, Hanno –con worsening of symptoms • Parsons: sensitivity 80% specificity 93% • Most patients can figure out the proper diet based on • Intravesical Anesthetic Challenge this elimination

28 Parsons et al., 2002 Butrick et al., 2010

TreatmentTreatment TreatmentTreatment

• Pentosan polysulfate sodium (Elmiron) • Only FDA approved medication for IC/PBS • Replenishes defective GAG layer • Inhibits mast cell degranulation • Start 100 mg TID and reassess in 3 months • Mixed results: • Effective in ≈ 30% of patients and it may take 6 months to see the effect • 45‐50% improvement in 32 weeks of treatment (RCT) • Improves frequency more than pain

29 30 Parsons et al., 2002

30 TreatmentTreatment TreatmentTreatment

• Pentosan polysulfate sodium (Elmiron) • Amitryptiline • Blocks Ach and H1 receptor • Anticholinergic and sedative • Decreases symptoms of urgency • Start 10 mg/day and titrate up • Effective doses 50‐75 mg/day • Side effects: Nausea, constipation, drowsiness • 63% of patients satisfied with treatment (RCT)

31 32

TreatmentTreatment TreatmentTreatment

• Hydroxizine • Gabapentin (Neurontin) • Blocks H1 receptor • Mimics GABA receptor activation by an • Decreases mast cell activation • Doses 10‐75 mg/day independent mechanism to modify pain response • Side effect s: DDirowsiness, constipati on, dry mouth • Start at 300 mg/day and titrate up to 3600 • Mixed results mg/day • 40% improvement in symptom scores • Side effects: Nausea, drowsiness and constipation • 55% improvement in patients with seasonal allergies • No better than placebo in quality of life and number of voids • 50% of patients report improvement of symptoms (RCT) (CS)

33 34

TreatmentTreatment TreatmentTreatment

35 36

31 TreatmentTreatment TreatmentTreatment

• Physical therapy • Intravesical therapy • Decrease pelvic floor • DMSO muscle spasm • Heparin and alkalinized lidocaine • Release of painful scars • Pentosan polysulfate (Elmiron)

37 38

TreatmentTreatment TreatmentTreatment

• Cystoscopy with hydrodistention (therapeutic) • Cystoscopy with hydrodistention (therapeutic) • Fill bladder with saline to pressure of 80 cm of water • Outcomes • 0 minutes • ≈ 60%of patients have improvement of symptoms • 6 minutes • Improvement lasts f or approxiilmately 3 month s • Prolonged • Complications • Mechanism of action: • Bladder perforation 2‐3% • Increases HB‐EGF and decreases AFP • Bladder necrosis (extremely rare) • Damage to submucosal nerve plexus and stretch receptors

39 40

Botulinum toxin TreatmentTreatment

• Botulinum toxin A + HD • GRA improvement 3 months 72% vs. 48% HD only th On August 25 2011 FDA approved Botulinum • Success at toxin A for treatment of incontinence due to • 3 months – 69% overactive bladder in people with spinal cord • 6 months – 45% injuries and multiple sclerosis (not IC) • 12 months – 26% • No statistical difference between 100u and 200u of BtxA

41 42

32 TreatmentTreatment

• Treatments that should not be offered: • Long term oral antibiotics • Intravesical instillation of BCG (Bacillus Calmette‐ Guérin) • Intravesical instillation of RTX (Resiniferatoxin) • High pressure long term hydrodistention (> 100 cm H2O and > 10 min) IRRITABLE BOWEL SYNDROME • Systemic long term glucocorticoids

43

Irritable bowel syndrome Subtypes

• Recurrent abdominal pain or discomfort at least 3 days a month for the past 3 months, associated with two of the following: • IBS‐D predominant diarrhea improvement with defecation, onset • IBS‐C predominant constipation associated with a change in frequency of stool or onset associated with a change in form of • IBS‐A alternating stool • IBS‐PI post‐infectious • 10‐15% population meet these criteria

Rome III criteria 2006

Etiology Comorbidities

• Headache • Endometriosis • Fibromyalgia • Interstitial cystitis • Unknown • Chronic fatigue • Inflammatory bowel • Psychological factors – “derailing of brain‐gut syndrome disease axis” • Depression • Unnecessary surgery • Post‐infectious –small intestinal bacterial (cholecystectomy) overgrowth

Mayer, 2008 Whitehead et al., 2002

33 Irritable bowel syndrome Diagnosis

• History • Patients with IBS are more likely to undergo: • Physical examination – Cholecystectomy x 3 • Routine laboratory studies not including – Hysterectomy x 2 colonoscopy

Longstreth & Yao, 2004 Mayer, 2008

Diagnosis Treatment

• Diet • Medications • Cognitive behavioral therapy • Stress relief • Alternative medicine – Probiotics, herbal remedies, yoga, acupunctirure

Mayer, 2008 Mayer, 2008

Treatment Conclusions

• Chronic pelvic pain is often caused by multiple conditions • Interstitial cystitis, irritable bowel syndrome, pelvic floor tension myalgia are often present in addition to other conditions (endometriosis) • All those have to be recognized and treated

Mayer, 2008

34 References References

• Berry, S. H., Elliott, M. N., Suttorp, M., Bogart, L. M., Stoto, M. a, Eggers, P. , Nyberg, L., et al. • Issa, B., Onon, T. S., Agrawal, a, Shekhar, C., Morris, J., Hamdy, S., & Whorwell, P. J. (2012). (2011). Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult Visceral hypersensitivity in endometriosis: a new target for treatment? Gut, 61(3), 367 females in the United States. The Journal of Urology, 186(2), 540–4. • Koziol, J. A., Clark, D. C., Gittes, R. F., & Tan, E. M. (1993). The natural history of interstitial • Butrick, C. W. (2003). Intersitial Cystitis and Chronic Pelvic Pain: New Insights in cystitis: a survey of 374 patients. The Journal of Urology, 149(3), 465–9 Neuropathology, Diagnosis and Treatment. Clinical Obstetrics and Gynecology, 46(4), 811– • Koziol, J. A. (1994). Epidemiology of interstitial cystitis. The Urology Clinic of North America, 21(1), 7–20. 823. • Longstreth, G F, Preskill, D. B., & Youkeles, L. (1990). Irritable bowel syndrome in women • Butrick, C. W., Howard, F. M., & Sand, P. K. (2010). Diagnosis and treatment of interstitial having diagnostic laparoscopy or hysterectomy. Relation to gynecologic features and cystitis/painful bladder syndrome: a review. Journal of Women’s Health, 19(6), 1185–93. outcome. Digestive diseases and sciences, 35(10), 1285–90. • Chung, M. K., Chung, R. P. , & Gordon, D. (2005). Interstitial cystitis and endometriosis in • Mayer, E. (2008). Irritable bowel syndrome. New England Journal of Medicine, 358(16), 1692– 1699. patients with chronic pelvic pain: The “Evil Twins” syndrome. JSLS 9(1), 25–9. • Parsons, C. L., Dell, J., Stanford, E. J., Bullen, M., Kahn, B. S., Waxell, T., & Koziol, J. A. (2002). • Driscoll, a, & Teichman, J. M. (2001). How do patients with interstitial cystitis present? The Increased prevalence of intersitial cystitis: previously unrecognized urologic and gynecologic Journal of urology, 166(6), 2118–20. cases identified usling a new symptom questionnaire and intravesical potassium sensitivity. Urology, 60(4), 573–578. • Evans, R. J. (2002). Treatment Approaches for Interstitial Cystitis: Multimodal Therapy. • Whitehead, W. E., Palsson, O., & Jones, K. R. (2002). Systematic review of the comorbidity of Reviews in Urology, 4(1), 16–20. irritable bowel syndrome with other disorders: What are the causes and implications? • Howard, F. M. (2011). Surgical treatment of endometriosis. Obstetrics and Gynecology Clinics Gastroenterology, 122(4), 1140–1156. of North America, 38(4), 677–86.

35 Disclaimer

• I have no financial relationships to disclose. Surgical Intervention in Patients with Chronic Pelvic Pain

Georgine Lamvu, MD, MPH Director of MIS and Advanced Gynecology Fellowship Medical Director of Gynecology Florida Hospital Orlando

Lamvu, AAGL 2012 1 Lamvu, AAGL 2012 2

Epidemiology Surgical Intervention Objectives for CPP • Review the evidence on surgical treatment of • In the U.S. CPP is the primary indication for pelvic pain – 40% of laparoscopies • Discuss the role of hysterectomy in the – 12% of management of pelvic pain – Less than 5% of patients with chronic pain • Review summary recommendations for disorders are actually seen by pain specialists surgical pain intervention

Agency or Healthcare Research and Quality Effective Health Care Program. Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness, 2012.

Lamvu, AAGL 2012 3 Lamvu, AAGL 2012 4

Chronic Pelvic Pain Surgical Treatment for CPP Etiology and Treatments Indications for Surgery Types of Surgery • To avoid side effects of Coagulation / resection of endometriosis Musculo‐ lesions- Gastrointestinal Urologic Reproductive medical therapies Skeletal Adhesiolysis 37% 31% 20% 12% • To provide relief in In cases of failed medical Ovarian cystectomy management SliSalpingec tomy Diet Diet Hormonal Muscle Stimulants Elmiron Regulation Relaxants • To improve fertility Uterosacral transection (LUNA) Bulking Mast cell Surgical Physical Anti- Inhibitors Therapy • The opportunity for prompt Uterine suspension spasmodics Anesthetics Motility or definitive management? Drugs Presacral neurectomy (PSN) Analgesics Oophrectomy Mood Stabilizers Sleep Therapy Hysterectomy,+/- oophrectomy Sexual Therapy Cognitive Behavioral Therapy Lamvu, AAGL 2012 5 Lamvu, AAGL 2012 6

36 Adhesiolysis

What is the Evidence for Using Surgical Interventions to Treat Chronic Pelvic Pain?

Lamvu, AAGL 2012 7 Lamvu, AAGL 2012 Peters, 1992 (Source: Cochrane database). 8

Adhesiolysis Adhesiolysis

• Swank DJ, et al. Laparoscopic adhesiolysis in • May help patients patients with severe adhesions: patients with chronic abdominal pain: a – Infertility especially if tubal anatomy is “very” blinded randomised controlled multi‐centre distorted trial. Lancet, 2003, 361(9365): 1247‐51 – Pelvic pain if uterine anatomy is distorted ((ge.g. adhesions post cesarean delivery) – Adhesiolysis at diagnostic laparoscopy vs. – Severe bowel dysfunction if adhesions restrict motility diagnostic laparoscopy of bowel – Adhesiolysis N=51 vs. Diagnostic N=47 • Remember to biopsy adhesions – No significant differences in VAS pain score at 12 • Remember to use intra‐pelvic fluid (LR, saline) or other adhesion barrier device or fluid months between two groups (both improved)

Lamvu, AAGL 2012 9 Lamvu, AAGL 2012 10

Uterosacral Nerve Ablation (UNA) Uterosacral Nerve Ablation (UNA)

. Pooley AS, et al. Fertil Steril. 1997;68:1070‐1074. . Daniels J, et al. Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain: a randomized controlled . Vercellini P, et al. Fertil Steril. 1997;68:393‐401. trial, JAMA, 2009, 302 (9):955‐61. . LUNA at diagnostic laparoscopy vs. diagnostic laparoscopy alone . Lappparoscopic UNA in addition to endometriosis surggyery . No significant differences in pain improvement between the two does not have additional effect on pain relief . Johnson NP, et al. A dbldouble‐blin d randddomised controlle d trial of laparoscopic uterine nerve ablation for women with chronic pelvic pain. BJOG, 2004, 111(9): 950‐9. . Differences in pain from baseline and no differences between the two groups . Looked for more than 50% improvement

Lamvu, AAGL 2012 11 Lamvu, AAGL 2012 12

37 Uterine Suspension for the Presacral Neurectomy (PSN) Retroverted Uterus • Two randomized trials • Uterine Suspension – Tjaden B, et al. Obstet Gynecol. 1990;76:89. – 1st described in 1882 – Candiani GB, et al. Am J Obstet Gynecol. 1992;167:100‐103. – ~200 methods (including 12 laparoscopic methods) described in the literature • No difference in overall pain relief compared to surgical – Many past indications treatment of endometriosis alone • Dysmenorrhea, pelvic pain, infertility, back pain • Both suggest PSN is beneficial when midline pain is present, • Most did not provide long term cure but of no value for other pain – Dypareunia secondary to penile collision with a retroverted uterus & suspension following excision of deep cul‐de‐sac endometriosis • 90% of patients with PSN experienced constipation remain currently accepted indications postoperatively

Lamvu, AAGL 2012 13 Lamvu, AAGL 2012 14

Current Evidence for Uterine MUST Study Suspension Perry CP, Presthus J, Nieves A. Laparoscopic uterine suspension for pain relief. J Reprod Med 2005 • Dyspareunia • Uncontrolled prospective cohort (N=62) – Carter: 85% (n = 64) reported pain reduction from 8.1 to 1.5 on a 10‐ point scale –up to 24 months follow‐up • All VAS scores significantly decreased • J Repro Med 44:417, 1999 (p<0.0001) post op • Dysmenorrhea – Ostrzenski – 87. 5% (n=28) experienced relief – at least 24 months • At least 50% Improvement of: follow‐up • J Repro Med 43:361, 1998 – Chronic Pelvic Pain 57% – Carter – 100% (n=75) reported pain reduction from 8.4 to 1.7 on a 10‐ point scale ‐ up to 24 months follow‐up – Dysmenorrhea 46% • J Repro Med 44:417, 1999 – Dyspareunia 81%

Lamvu, AAGL 2012 15 Lamvu, AAGL 2012 16

Conservative Surgical Treatment

• Adhesiolysis‐ may improve pain relief or fertility when anatomy is severely affected

• Presacral Neurectomy – may be effective but only for treatment of “midline” pain. May cause constipation and urinary urgency WHAT EVIDENCE SUPPORTS THE USE OF • Uterosacral Neurectomy (LUNA) –studies show HYSTERECTOMY TO TREAT CHRONIC minimmal to no benefit PELVIC PAIN?

Lamvu, AAGL 2012 17 Lamvu, AAGL 2012 18

38 Hysterectomy Outcomes in Non‐ Hysterectomy Outcomes in Women Painful Gynecologic Conditions with Chronic Pelvic Pain Kjerulf KH, 2000. Carlson KJ, 1997. Rhodes JC, 1999. • Stovall TG, Ling FW, Crawford DA, 1990 – 99 women with idiopathic chronic pelvic pain • Major complication rate is less than 5% – 22% reported continued pelvic pain after hysterectomy – Women were thought to have clinical and histologic • Vaginal, laparoscopic and robotic techniques evidence of uterine disease with shthort hitlhospital stays (< 48hrs ) and rapid • Hillis SD, Marchbanks PA, Peterson HB, 1995 recovery – 308 women with chronic pelvic pain, 1 year after hysterectomy • Up to 95% of women who undergo – 21% had continued but decreased pain hysterectomy report improvement of – 5% had unchanged or increased pain symptoms and up to 80% report – In specific subsets up to 40% had continued pain • Age <30 years, uninsured, history of PID, without an improvement in sexual function 12 months identifiable pathology at the time of surgery after surgery Lamvu, AAGL 2012 19 Lamvu, AAGL 2012 20

Hysterectomy Outcomes in Women Risk Factors for Chronic Pelvic Pain with Chronic Pelvic Pain After Hysterectomy • Hartmann KE, Ma C, Lamvu GM, Langenberg PW, • Brandsborg B, Nikolajsen L, Hansen CT, Kehlet Steege JF, Kjerulff KH, 2004 H, Jensen TS, 2007. – 1200 women monitored for 24 months after hysterectomy – Women with pre‐operative pain vs. women with pre‐ – Danish nationwide survey of 1299 women, 1 year operative pain and depression vs. women with pre‐ after hysterectomy operative depression, all compared to a control group – – 78‐86% of women had improvement after surgery Women with pre‐operative pelvic pain had 3x – 50% had improved physical or social function higher odds of continued pain – 14% had results worse than they expected – Women with pre‐operative pain elsewhere had 3x – 26% had recovery slower than expected higher odds of pelvic pain after surgery – Women with pre‐existing pain or depression were 3‐5 – 14% of women reported new onset pain after times more likely to have impaired quality of life, pelvic pain and dyspareunia than controls. surgery

Lamvu, AAGL 2012 21 Lamvu, AAGL 2012 22

Potential Causes of Chronic Pelvic Pain • More than 70% of chronic pelvic pain has potentially non‐gynecologic etiology, a matter of missed diagnosis – 90% of women do not undergo a full multidisciplinary evaluation before surgery • Certain pathophysiology of certain subtypes of chronic pelilvic pain may not b e amenddblable to surgilical treatment – IC – IBS WHY DIFFERENT OUTCOMES IN – Pelvic floor myalgia WOMEN WITH CHRONIC PELVIC PAIN? • Certain pathophysiology may affect multiple organs and removal of one organ may not be enough

Lamvu, AAGL 2012 23 Lamvu, AAGL 2012 24

39 Neurophysiology of Pain

• Pathways of chronic pain may be centrally established and not amendable to peripheral organ surgery • The subjective ex perience of pain and recovery from may be affected by the environment, psychological state of the What can we do for our patients with chronic pelvic pain now? patient RECOMMENDATIONS – Psychiatric, environmental and relationship dysfunction may potentiate persistence of pain

Lamvu, AAGL 2012 25 Lamvu, AAGL 2012 26

Recommendations Pre‐operative Discussion

1. Improve the consent and pre‐operative • Up to 40% of women may have continued counseling process pain 2. Perform a full multi‐system evaluation before • Up to 5% may have worse pain after surgery surgery • Up to 30% have a recovery much slower than expected 3. Discuss additional therapies that target pain • and function Patients should consider alternative options such as analgesics, hormonal therapy, physical 4. Improve pre‐operative, intra‐operative and therapy, neural blocks, complimentary post‐operative pain management alternative therapy and cognitive behavioral therapy that improve coping Lamvu, AAGL 2012 27 Lamvu, AAGL 2012 28

Perform and Document a Multi‐ Discuss Additional Therapies System Pre‐Operative Evaluation Some May Need to Be Continued After Surgery • Urinary symptoms • Urinary symptoms and function – Bladder retraining, diet, physical therapy, bladder antispasmotics • Gastrointestinal symptoms and function • Gastrointestinal – Bowel regimen to address constipation or diarrhea • Musculoskeletal evaluation • Musculoskeletal – Physical therapy, muscle relaxants • Other chronic pain syndromes • Other chronic pain syndromes – Analgesics, antiepieleptics, antidepressants • Psychiatric dysfunction • Psychiatric dysfunction – Antidepressants, cognitive behavioral therapy • Sexual function and pain function • Sexual function and pain function – Sexual counseling • Physical function and disability • Physical function and disability – Physical therapy

Lamvu, AAGL 2012 29 Lamvu, AAGL 2012 30

40 Pain Management Before, During and After Surgery

• Pre‐operative Agency or Healthcare Research and – Neuroleptics, antidepressants, physical therapy Quality Effective Health Care Program • Intra‐operative – Acetominophen, NSAIDS January 2012 • Post‐operative Noncyclic Chronic Pelvic Pain Therapies – Consider scheduled vs. “as needed” dosing for Women: Comparative Effectiveness – Consider a pre‐op epidural or post‐op PCA – Adjust dosing for patients who previously used opioids – Investigate post‐operative acute pain

Lamvu, AAGL 2012 31 Lamvu, AAGL 2012 32

Research Findings

Key Question 2 • Evaluated literature on diagnostic laparoscopy, laparotomy, hysterectomy, adhesionlysis, LUNA and PSN studies did not meet criteria. Uterine suspension Among women with CPP what is the was not evaluated. effect of surgical intervention on pain • Comparison to medical therapy, sham surgery and no therapy status, functional status, satisfaction with • 7 studies: 5 were RCTs, 2 were prospective cohort care and quality of life? • 3 compared to non‐surgical, 4 compared to diagnostic laparoscopy or other surgery • All studies had varying definitions for CPP • 1 was considered good quality, 1 fair and 5 as poor

Lamvu, AAGL 2012 33 Lamvu, AAGL 2012 34

AHRQ Conclusions Summary

• Prior to surgery document the presence and location of pain, • Surgical and non‐surgical interventions both chronicity, associated symptoms and counseling improved pain status, but neither was more • Counsel patients with CPP that surgery may have diagnostic benefits but not necessarily therapeutic benefits. Document effective than the other counseling on risk of complications but also risk of: – Failure to treat pain • LOA and LUNA did not improve pain over – Risk of slower or prolonged recover – Risk of worsening of pain diagnostic laparoscopy • Emphasize a multidisciplinary evaluation for pain prior to surgery and counsel that this option was given… and the patient had a chance to think about it. Do rush patients with chronic pain to surgery unless you suspect an acute process. • Discuss and optimize pre‐operative and post‐operative pain management • LUNA is a dead horse, stop beating it.

Lamvu, AAGL 2012 35 Lamvu, AAGL 2012 36

41 Summary References

. Lamvu G. Role of Hysterectomy in the Treatment of Chronic Pelvic Pain. Obstetrics and Gynecology, May 2011, vol 117 (5); pp 1175. . Agency or Healthcare Research and Quality Effective Health Care Program. Noncyclic • When it comes to surgical Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness, 2012. . Swank DJ, et al. Laparoscopic adhesiolysis in patients with chronic abdominal pain: a blinded randomised controlled multi‐centre trial. Lancet, 2003, 361(9365): 1247‐51 outcomes for the treatment of . Pooley AS, et al. Fertil Steril. 1997;68:1070‐1074. . Vercellini P, et al. Fertil Steril. 1997;68:393‐401. . Brandsborg B, Nikolajsen L, Hansen CT, Kehlet H, Jensen TS, 2007. CPP we have a lot of work to do! . Hartmann KE, Ma C, Lamvu GM, Langenberg PW, Steege JF, Kjerulff KH, 2004 . Stovall TG, Ling FW, Crawford DA, 1990 . Hillis SD, Marchbanks PA, Peterson HB, 1995 • If you are not a researcher . Daniels J, et al. Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain: a randomized controlled trial, JAMA, 2009, 302 (9):955‐61. . Johnson NP, et al. A double‐blind randomised controlled trial of laparoscopic uterine continue to follow your patients nerve ablation for women with chronic pelvic pain. BJOG, 2004, 111(9): 950‐9. . Kjerulf KH, 2000. Carlson KJ, 1997. Rhodes JC, 1999. . Perry CP, Presthus J, Nieves A. Laparoscopic uterine suspension for pain relief. J long term… Reprod Med 2005

Lamvu, AAGL 2012 37 Lamvu, AAGL 2012 38

THANK YOU

Lamvu, AAGL 2012 39

42 Disclosure

• I have no financial relationships to disclose What if surgery causes pain? Michael Hibner, MD, PhD, FACOG, FACS Director, Division of Surgery and Pelvic Pain St. Joseph’s Hospital and Medical Center, Phoenix, Arizona Professor of Obstetrics and Gynecology Creighton University School of Medicine

Objectives

• To identify causes of de novo pain after gynecologic surgery • To describe diagnostic process in those cases • To present availa ble treatments for de novo pain after gynecologic surgery

Clinical scenario 1 Clinical scenario 1

45 year old CSx2 undergoes robotic hysterectomy for symptomatic uterine leiomyomata. Surgery is uncomplicated and On day 4 she is still not able to void completely patient is discharged home on POD #1. Because and Foley catheter is kept for another week. She she is unable to pass the voiding trial she is returns for a 6 week visit and notices significant discharged with the leg bag and asked to return pain with speculum exam. Vaginal cuff is healed totheofficein2‐3days.Sheisalsoinstructedto and patient is allowed to have intercourse. refrain from intercourse for 6 weeks.

43 Clinical scenario 1 Clinical scenario 1

She calls back complaining of significant pain with intercourse as well as worsening hesitancy. On repeat physical exam vaginal cuff is intact but speculum causes significant pain. Digital exam reveals significant tenderness of the and the bladder

Incidence of postsurgical pain Postsurgical pain

• Study of 1299 women undergoing hysterectomy – 31.9% had pain 1 year after hysterectomy – 14.9% de novo pain – Risk factors: • previous cesarean delivery (OR 1.54), • pain as indication for surgery (OR 2.98) • pain problems elsewhere (OR 3.19) – No difference between the routes of hysterectomy – Spinal anesthesia decreases the risk (OR 0.42)

Bransborg et at., 2007

Possible etiology Visceral and referred pain

Giamberardino et al., 2010

44 Pelvic floor muscles

PELVIC FLOOR TENSION MYALGIA

Symptoms Examination of pelvic floor muscles

• Pain with stretching of pelvic floor muscles Obturator Internus – Intercourse and postcoital dyspareunia Pubococcygeous – Gynecological exam X X – Most of activities involving lower extremities Iliococcygeous • X Hesitancy X Coccygeous • Sensation of incomplete voiding X Pyriformis

Butrick, 2009

Diagnosis Diagnosis

Prendergast, 2003 Butrick, 2009

45 Treatment Treatment

Identify Underlying Cause • Valium 5mg/Baclofen 4 mg vaginal dysbehavoirs, trauma, surgery, inflammation, pain suppository • Belladonna 16.2 mg/Opium 30 mg rectal Treat ppperpetuatin g factors suppository IC Endometriosis

Treat Pelvic Floor Muscle relaxation Central Sensitization

Howard et al., 2000 Hibner et al., 2010

Treatment Treatment

• Botulinum toxin A (Botox) • Done under anesthesia/sedation • Examine patient prior to sedation to identify most tender areas • After sedation do pudendal nerve block with 0.5% BiBupivaca ine with epihiinephrine • Dilute 200 units of Botulinum toxin in 20 ml of NS • Inject using pudendal nerve block needle at volumes 1 ml per injection deep into levator and obturator muscles • Usually patients start feeling relief from Botox about a week after the injection. If no relief and muscles feel relaxed pain is most likely due to nerve injury, not muscle spasm

Prendergast, 2003 Abbott, 2008

Treatment Treatment

46 Outcomes Clinical scenario 2

55 year old SVD x 3 is diagnosed with grade • 70% experience improvement of pain 3 uterine prolapse, • 99% effective in producing muscle relaxation grade 3 cystocele and • Effect last for 3‐4 months grade 2 rectocele. Patient • 80% effective for patients with bladder pain undergoes uneventful vaginal syndrome hysterectomy and Prolift® mesh repair.

Hibner et al. 2010

Clinical scenario 2 Clinical scenario 2

Patient wakes up from surgery in PACU and immediately starts complaining of severe rectal pain. Pain management is called to see patient. She is started Pain seems to be located on the right side only. on Hydromorphone, Baclofen, Gabapentin and pain She is given several doses of narcotics becomes tolerable. She is transitioned to long acting which only partially help her. narcotics and discharged home. At 6 week visit vaginal Pain is exacerbated by any movement epithelium and all the incisions are healed. Pain is unchanged and almost unbearable. Patient is unable to and especially by sitting. sit at all and cannot preform her daily activities.

Symptoms

• Pain in the area of innervation of the pudendal nerve • Pain is neuropathic in nature • Paresthesia – burning, tingling, prickling, numbness sensation • Allodynia – pain in resp onse to non painful stimulus • Hyperalgesia –pain out of proportion to the stimulus • Pain is more severe with sitting • Pain absent or significantly less when lying down • Pain less when sitting on the toilet vs. chair PUDENDAL NEURALGIA • Sensation of foreign body in the rectum or vagina (allotriesthesia)*

Hibner et al., 2010

47 Symptoms Causes

• Urinary symptoms – frequency, urgency, • Caused by injury to the pelvic floor by: hesitancy • Surgery • Direct –mesh injury • Dyschesia • Indirect –hysterectomy, cystocele repair, prolapse repair • Vaginal childbirth • Dyspareunia • Trauma • Falls • Pain with orgasm • Cycling • Intense lower extremity exercise • Pain with sexual arousal (abductor machine) • Excessive masturbation • Persistent sexual arousal • Excessive use of anal vibrators

Hibner et al., 2010 Hibner et al., 2010

Pelvic floor pain syndrome

Pelvic floor Pelvic floor Mechanical Disease of muscle spasm muscle spasm nerve the nerve compressing compression (HSV, DM) the nerve •Physical •Physical •Surgical •Treatment of therapy + therapy + decompression underlying botulinum toxin botulinum toxin disease

Hibner et al., 2010 Hibner et al., 2010

Diagnosis Diagnosis • History • Pudendal nerve motor terminal latency (PNMTL) • Pain in the area of pudendal nerve (but often there is • Unreliable in multiparous patients also pain outside elsewhere –lower back, anterior • High interobserver and intraobserver variability and posterior thighs, sciatica) • Sensory threshold testing • Onset of pain coincides with traumatic event(s) • Warm detection threshold testing • If no traumatic event PFTM more likely • Two point discrimination testing • If bilateral pain PFTM more likely • MRI • Exam • Anatomical MRI • Functional MRI (MR neurography) • Significant tenderness to palpation along the course of • Alcock’s canal (vaginal) Diagnostic CT guided pudendal nerve block • Patients must have at least temporary relief of pudendal neuralgia • Palpation of the course of the nerve reproduces (part of Nantes criteria) symptoms (Tinel’s sign)

Hibner et al., 2010 Hough et al., 2003

48 Treatment Treatment

• Self care –avoidance of pain, use of sitting support • Pelvic floor physical therapy • Oral medications • Gabapentin (Neurontin) up to 2400 mg/day • Pregabalin (Lyrica) start at 75 mg BID up to 600 mg daily • Amitryptiline 25‐50 mg/day • Duloxetine (Cymbalta) • Appropriate pain management (narcotics) • Suppositories • Belladonna and Opium 16.2/30 mg rectal suppository BID • Diazepam 5 mg/Baclofen 4 mg vaginal suppository BID

Hibner et al., 2010 Prendergast, 2003

Treatment Treatment

• Therapeutic CT guided pudendal nerve block • Bupivacaine 0.5% with epinephrine • Triamcinolone (Kenalog) 80 mg (40 mg per side if bilateral) • Injections repeated every 6 weeks (3 total)

McDonald & Spigos, 2000

Treatment Treatment

49 Treatment Outcomes

Conservative SurgerySurgery management

33 monthsmonths 62%6.2% 50%

12 months 13.3% 71.4%

48 months 50%

Improvement defined as decrease in VAS by 3 and decrease of behavioral quality of life to ≤ 3

Robert et al., 2005

In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, Audience: Health care providers who implant surgical mesh to repair pelvic organ prolapse 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of and/or stress urinary incontinence complications associated with surgical mesh devices used to repair POP and SUI, Health care providers involved in the care of patients with surgical mesh implanted with 1,503 reports associated with POP repairs and 1,371 associated with SUI to repair pelvic organ prolapse and/or stress urinary incontinence repairs. Although it is common for adverse event reporting to increase following an Patients who are considering or have received a surgical mesh implant to repair FDA safety communication, we are concerned that the number of adverse event pelvic organ prolapse and/or stress urinary incontinence reports remains high.

Symptoms from Mesh Complications

Pelvic Both mesh erosion and mesh contraction may lead to severe pelvic pain, Neurological Floor painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual Clitoral Hesitancy intercourse when the mesh is exposed in mesh erosion. pain Vaginal The complications associated with the use of surgical mesh for POP repair Dyspareunia have not been linked to a single brand of mesh. pain Rectal Bladder pain pain

Castellanos, AAGL 2012

50 Mesh injury Treatment

• Requires immediate attention and possible removal of mesh • All mesh should be removed, no partial resection • Vaginal resection of mesh may not remove the mesh from the pudendal nerve

Castellanos et al., AAGL 2012 Castellanos et al., AAGL 2012

Route of removal of mesh Mesh removal ‐ evidence

Castellanos et al., AAGL 2012

Prolift®

Ridgeway et al., 2008 Castellanos, AAGL 2012

51 Prolift® References

• Abbott, J. (2008). The use of botulinum toxin in the pelvic floor for women with chronic pelvic pain‐a new answer to old problems? Journal of minimally invasive gynecology, 16(2), 130–5. • Butrick, C. W. (2009). Pelvic floor hypertonic disorders: identification and management. Obstetrics and gynecology clinics of North America, 36(3), 707–22. • Bransborg, B., Nikolajsen, L., Hansen, C. T., Kehlet, H., & Jensen, T. (2007). Risk Factors for Chronic Pain after Hysterectomy. Anesthesiology, 106(5), 1003–1012. • Castellanos ME, Yi J, Atashroo D, Hibner M. Pudendal neuralgia after placemen of mesh kits for posterior vaginal wall repair: An anatomical study and case series. Global Congress of Minimally Invasive Gynecology. Las Vegas, Nevada, November 2012 • Giamberardino, M. A., Costantini, R., Affaitati, G., Fabrizio, A., Lapenna, D., Tafuri, E., & Mezzetti, A. (2010). Viscero‐visceral hyperalgesia: characterization in different clinical models. Pain, 151(2), 307–22. Right (mm) Left (mm) • Hibner, M., Desai, N., Robertson, L. J., & Nour, M. (2010). Pudendal neuralgia. Journal of Minimally Invasive Gynecology, 17(2), 148–53. • Hibner M, Castellanos ME, Bochenska K, Desai N, Wadsworth L, Balducci J. Onabotulinum toxin A in treatment of chronic pelvic pain associated with pelvic floor tension myalgia. Poster presentation at International Pelvic Pain Society Meeting. Chicago, Illinois, October 2010 • Hough, D. M., Wittenberg, K. H., Pawlina, W., Maus, T. P., King, B. F., Vrtiska, T. J., Farrell, M. A., et al. (2003). Chronic Perineal Pain Caused by Pudendal n. 15.6 (± 2.5) 18.0 (± 2.9) Pudendal Nerve Entrapment: Anatomy and CT‐Guided Perineural Injection Technique. American Journal of Roentgenology, 181(August), 561–567. • Howard, F. M., Perry, P., Carter, J., & El‐Minawi Ahmed M. (2000). Pelvic Pain: Diagnosis and Management (1st ed., p. 529). Lippincott Williams & Wilkins. Inferior rectal n. 11.0 (± 1.5) 8.3 (± 2.6) • McDonald, J. S., & Spigos, D. G. (2000). Computed tomography‐guided pudendal block for treatment of pelvic pain due to pudendal neuropathy. Obstetrics and gynecology, 95(2), 306–9. • Prendergast, S. A. (2003). Causes of Pelvic Pain. Clinical obstetrics and gynecology, 46(4), 773–782. • Ridgeway, B., Walters, M. D., Paraiso, M. F. R., Barber, M. D., McAchran, S. E., Goldman, H. B., & Jelovsek, J. E. (2008). Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits. American journal of obstetrics and gynecology, 199(6), 703.e1– 7. • Robert, R., Labat, J.‐J., Bensignor, M., Glemain, P., Deschamps, C., Raoul, S., & Hamel, O. (2005). Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long‐term evaluation. European urology, 47(3), 403–8.

Castellanos, AAGL 2012

52 Disclosure

• I have no financial relationships to disclose. Surgical Treatment of Endometriosis

Georgine Lamvu, MD, MPH Director of MIS and Advanced Gynecology Fellowship Medical Director of Gynecology Florida Hospital Orlando

Lamvu, AAGL 2012 1 Lamvu, AAGL 2012 2

Objectives Definition of Endometriosis

• Review the evidence surrounding surgical • " the presence of ectopic treatment of endometriosis tissue which possesses • Discuss the role of infertility and pain when the histological structure considering sur gical treatment of … of the uterine mucosa" – Sampson (1921) endometriosis • Affects 10‐15% of • Review final recommendations for reproductive age women management of endometriosis • Diagnosis – Requires tissue specimen – Ectopic endometrial glands & stroma must be present

Lamvu, AAGL 2012 3 Lamvu, AAGL 2012 4

Pain and Stage May Not Be Related Why are Pain and Stage Unrelated?

• Early lesions are small but may be more immunologially active Symptoms – Vernon MW, et al. Fertil Steril. 1986;44:801-806 Most common symptom is • More than 80% of patients have endometriosis in the presence dysmenorrhea of other pain generators such as: IBS, IC, myofascial pain. 40% have dyspareunia – Howard FM. J Am Assoc Gynecol Laparosc, 1994; 1:325. – 60% have non‐menstltrual chihronic Howard FM. Obstet Gynecol Clin N Am, 200;11; 38:677. pelvic pain • Not all endometriosis is alike Pain and staging – Cornillie, et al found that deeply infiltrating endometriosis was most commonly correlated with pain and superficial endometriosis was • Stage I: 40% more commonly associated with infertility • Stage II: 24% Fertil Steril 53:978, 1990 – Ripps found focal tenderness on exam to highly correlate with the • Stage III: 24% presence of deeply infiltrating endometriosis, esp. in the cul de sac, • Stage IV: 12% and uterosacral ligaments Fedele L, et al. Fertil Steril. 1990;53:155-158. J Reprod Med 37:620, 1992 Lamvu, AAGL 2012 5 Lamvu, AAGL 2012 6

53 Surgical Therapy for Pelvic Pain Associated with Endometriosis: A Closer Look at the “Data”

What is the best surgical technique for removing endometriosis? Lamvu, AAGL 2012 7 Lamvu, AAGL 2012 8

Surgical Technique Laparoscopy vs. Laparotomy • Diagnostic, ablation, excision, adhesiolysis, nerve ablation • No level I evidence for use of laparotomy to treat • Laparoscopy or laparotomy endometriosis • Technical objectives of surgery • Laparoscopy is preferred – Restore normal pelvic anatomy – Better recovery, small – Destroy/remove all implants incisions • Clinical objectives of surgery – Allows treatment at – Relieve pelvic pain diagnosis – Restore (maintain) fertility Batemen et al. Fertil Steril 1994:62;690‐5 Howard. J Am Assoc Gynecol Laparosc 1994;1:325‐31 Howard. J Amer Assoc Gynecol Laparosc Howard FM. Obstet Gynecol Clin N Am, 2011; 38:677. 1994;1:325 10 Lamvu, AAGL 2012

Laparoscopic Treatment of Peritoneal Laparoscopic Treatment of Peritoneal Endometriosis Endometriosis • Abbott study is second RCT of • 2 RCTs for laparoscopic treatment of endometriosis surgical treatment – Both studies showed pain improvement by approximately 50% • Randomized to Delayed Surgery • Sutton CJ, et al. Prospective, randomized, double‐blind (DS) or Immediate Surgery (IS) controlled trial of laser laparoscopy in the treatment of – DS pelvic pain associated with minimal, mild and moderate • Diagnostic laparoscopy endometriosis. Fert Steril, 1994; 62:696. • 6 months later, surgical – Laser excision stage I, II, III. excision – 6 months, 62% of cases improved vs. 23% controls – IS – Patients in stage II and III improved, stage I did not • Excision at initial surgery • 6 months later, surgical On average, pain is decreased by 50% • Abbott J, et al. Laparoscopic excision of endometriosis: a excision of any recurrent randomized, placebo‐controlled trial. Fertil Steril 2004, 82: or residual endometriosis 878. – Excision of stages II, III, IV – At 6 months 80% of cases improved vs. 32% of controls Abbott J et al. Fertil Steril 2004;82:878‐84

Lamvu, AAGL 2012 11 Lamvu, AAGL 2012 12

54 Laparoscopic Excision vs. Ablation Deep Excision Technique

• Peritoneal disease • Elevate peritoneum – 2 RCTs • Dissect peritoneum and separate it from vital – Wright J, et al. A randomized trial of excision versus ablation for mild structures endometriosis. Fertil Steril, 2010; 94:2536. • Use minimal cutting energy to resect tissue – Healey M, et al. Surgical treatment of endometriosis: a prospective randomied double‐blinded trial comparing excision and ablation. Fertil Steril • Use fine grasping and cutting instruments 2010; 94:2536. • Resected area is always larger than you think but make • Endometriomas sure you resect with margins (5‐6mm)… mark tissue to – At least 4 RCTs and other prospective trials be resected (cautery dots or meth blue) – Fayez JA, et al. Obstet Gynecol, 1991; 78:660 • Use visualization aides: e.g. blood painting, close – Hemmings R, et al. Ferilt Steril, 1998; 70:527 contact, rectal probe – Beretta P, et al. Fertil Steril, 1998; 70:1176. • Pre‐operative bowel prep – Saleh A, et al. Fertil Steril 1999;72:322.

Lamvu, AAGL 2012 13 Lamvu, AAGL 2012 14

Laparoscopic Excision vs. Ablation Laparoscopic Excision vs. Ablation

• Peritoneal disease (2RCTs) • Endometriomas • No difference in relief of pelvic pain between the two – At least 4 RCTs and other prospective trials techniques – Fayez JA, et al. Obstet Gynecol, 1991; 78:660 – Caveat: bipolar coagulation only ablates to 2mm of depth, – Hemmings R, et al. Ferilt Steril, 1998; 70:527 best for superficial disease only – Beretta P, et al. Fertil Steril, 1998; 70:1176 . – For deeper lesions you may not ablate the entire lesion – Saleh A, et al. Fertil Steril 1999;72:322. – Ablation also leaves you blind to important structures • Recurrence of endometriomas is much less likely underneath the peritoneum with excision vs. ablation or coagulation – Ablation does not allow for biopsy of that tissue • Thermal energy to remove an endometrioma or – Types of ablation methods: RF electricity, Ultrasonics, Laser for hemostasis may lead to loss of ovarian reserve

Lamvu, AAGL 2012 15 Lamvu, AAGL 2012 16

Laparoscopic Treatment of Endometriomas Recurrence of Pain After Conservative Surgery (Stage I, II or III)‐

Laser vs. expectant management Three Months Six Months Sutton et al., 1994 Percentage decrease in VAS pain scores attributable to 14% 47% surgical treatment

Laser, diagnostic vs. expectant Three Months Six Months Twelve Months management (CI) (CI) (CI) Fred Howard, 2000 Rate of improvement with laser laparoscopic 56% ( 39-73%) 63% (46-79%) 59% (42-76%) treatment Rate of improvement with diagnositic 48% (33-66%) 23% (8-37%) ------laparoscopy only Absolute benefit increase 8% (-17-33%) 40% (18-62%) ------

Lamvu, AAGL 2012 17 Lamvu, AAGL 2012 18

55 Laparoscopy For the Treatment of CPP Recurrence of Endometriosis After Associated with Endometriosis Conservative Surgery • Jacobson TZ, et al. Laparoscopic surgery for pelvic • Approximated at pain associated with endometriosis. The Chochrane – 15% at 1 year database systematic reviews, 2006, Issue 4. – 36% at 5 years – Laparoscopic treatment of endometriosis is superior to diagnostic lappyparoscopy alone, OR for im provement =7.72 – 50% by 7 years (95%CI 2.97‐20.1) • Potential causes include incomplete resection or – Not all patients respond to removal of endometriosis, true disease especially in stage I disease • Endometriosis is not often identified in follow‐up – Placebo effect ranges from 22 to 32% of patients reporting improvement re‐operation studies of patients with CPP (i.e. – Response rate at 6 months, 66% to 80% of patients report continued pain is often found without recurrent improvement endometriosis lesions) Falcone T, et al. Obstetrics and Gynecology, 2011; 118(3): 691. Lamvu, AAGL 2012 19 Lamvu, AAGL 2012 20

Recurrence of Endometriomas Reoperation After Conservative Surgery

Busacca et al. Am J Obstet Gynecol 1999;180:519 Wheeler et al. Am J Obstet Gynecol 1983;146:247

Surgical Treatment for Endometriomas Surgical Treatment of Endometriosis and Impact on Infertility and Impact on Infertility • Surgical treatment in women with mild to • Two RCTs and one Chochrane review of laparoscopic treatment of endometriomas moderate endometriosis and infertility – Excision of cyst wall vs. cyst wall ablation OR 5.29; – Conflicting studies pregnancy rates 61% vs 23.4% within 2 years of surgery – Studies were done in women with pain and – 2003 Cochrane Database Meta‐analysis compared endtidometriomas > 3cm, dtdata has no t been replica te d in women with enddtiiometriosis who hdhad diagnos tic women with asymptomatic endometriomas – Concerns that excision diminishes ovarian reserve in laparoscopy vs. surgical treatment women who already have infertility/ studies suggest lower • Odds of pregnancy after surgical treatment =1.66 (95% antral follicle count after excision CI;(1.09‐2.51) – Removal of endometriomas is only recommended in symptomatic women, incidentally found endometriomas in • Odds of ongoing pregnancy beyond 20 weeks after surgical asymptomatic women should be left alone treatment = 1.64 (95%CI: 1.05‐2.57) • Excision, electracautery ablation and laser ablation yielded similar results Senapati, S, et al. Clinical Obstetrics and Gynecology, 2011, 54, Number 4, 720–726. Senapati, S, et al. Clinical Obstetrics and Gynecology, 2011, 54, Number 4, 720–726.

Lamvu, AAGL 2012 23 Lamvu, AAGL 2012 24

56 Numbers Needed to Treat with Surgical Ovulation Induction for Endometriosis Intervention to Improve Infertility in Women With Endometriosis Associated Infertility • In women with infertility and endometriosis, ovulation induction and IUI is beneficial and improves pregnancy rates • There is little doubt that the most beneficial treatment for infertility with endometriosis is IVF • However, success of ivf is inversely proportional to stage of disease, i.e. more severe disease has lowest NNT for excision, electrocautery ablation or laser ablation success rates Senapati, S, et al. Clinical Obstetrics and Gynecology, 2011, 54, Number 4, 720–726. Senapati, S, et al. .Clinical Obstetrics and Gynecology, 2011, 54, Number 4, 720–726.

Lamvu, AAGL 2012 25 Lamvu, AAGL 2012 26

Hysterectomy For Endometriosis Summary Associated Pain • Endometriosis has many clinical and surgical • With ovarian preservation (7 year follow up) presentations – 2 years 95% of women improve • – 5 years 86% Early surgical intervention is key (before chronic pain – 7 years 77% syndromes develop) • Without ovarian preservation (7 year follow up) • Pelvic pain is associated with endometriosis but – 2 years 96% endometriosis can be present with other pain causing – 5 years 91% cond it io ns, ppere‐oper ative eeauatovaluation of othe r oogargan – 7 years91% systems is important • However, there is no difference in rate of long term • Endometriosis has been linked to lower ovulation rates, improvement with or w/o ovarian preservation in women lower fertilization and lower implantation rates aged 30‐39 • If spontaneous conception fails, IVF is the treatment of • Recommendation from experts is to preserve ovaries in choice for patients with endometriosis associated young patients infertility Shakiba K, et al. Surgical treatment of endometriosis: a 7‐year follow up on the requirement for further surgery. Obstet Gynecol, 2008; 111: 1285. Falcone T, et al. Obstetrics and Gynecology, 2011; 118(3): 691 Lamvu, AAGL 2012 27 Lamvu, AAGL 2012 28

Summary References .Fedele L, et al. Fertil Steril. 1990;53:155‐158. .Fayez JA, et al. Obstet Gynecol, 1991; 78:660 • Aggressive surgical treatment may offer relief in higher stages .Vernon MW, et al. Fertil Steril. 1986;44:801‐ .Hemmings R, et al. Ferilt Steril, 1998; 70:527 806 .Beretta P, et al. Fertil Steril, 1998; 70:1176. .Howard FM. J Am Assoc Gynecol Laparosc, .Saleh A, et al. Fertil Steril 1999;72:322. • The type of surgery selected depends on the type of lesions 1994; 1:325. found .Howard FM. Obstet Gynecol Clin N Am, .Wheeler et al. Am J Obstet Gynecol 2011; 38:677. 1983;146:247 – Endometriomas should always be fully excised .Cornillie, et al. Fertil Steril 53:978, 1990 .Busacca et al. Am J Obstet Gynecol – Early and deep lesions may require careful excision .Ripps, J Reprod Med 37:620, 1992 1999;180:519 .Batemen et al. Fertil Steril 1994:62;690‐5 .Senapati, S, et al. .Clllinical Obstetrics an d – Additional adhesiolysis may benefit patients with very .Sutton CJ, et al. Fert Steril, 1994; 62:696. Gynecology, 2011, 54, Number 4, 720–726. .Abbott J, et al. Fertil Steril 2004, 82: 878. .Jacobson TZ, et al. The Chochrane database distorted anatomy (? Infertility) but may add little to pain systematic reviews, 2006, Issue 4. .Falcone T, et al. Obstetrics and Gynecology, relief 2011; 118(3): 691 . Falcone T, et al. Obstetrics and Gynecology, 2011; 118(3): 691. – Additional LUNA is not very beneficial .Wright J, et al. Fertil Steril, 2010; 94:2536. •Shakiba K, et al. Obstet Gynecol, 2008; 111: – Additional PSN neurectomy may be beneficial only in a few 1285. select patients .Healey M, et al.. Fertil Steril 2010; 94:2536. – Recurrence rates are high Lamvu, AAGL 2012 29 Lamvu, AAGL 2012 30

57 Disclosure

Less known conditions

causing chronic pelvic pain I have no financial relationships to disclose. Michael Hibner, MD, PhD, FACOG, FACS Director, Division of Surgery and Pelvic Pain St. Joseph’s Hospital and Medical Center, Phoenix, Arizona Professor of Obstetrics and Gynecology Creighton University School of Medicine

Objectives Case scenario

25 year old G1P2 is six months form vaginal delivery. She presents complaining of pelvic pain and sensation of pressure since delivery. • Identify some of the less know conditions Occasionally she has sharp shooting pain located leading to chronic pelvic pain. in the right lower quadrant. This sensation of pressure and sharp shooting pain usually happens with prolonged standing and sitting.

Case scenario Case scenario

You schedule patient for laparoscopy. The right side of the abdomen/pelvis looks normal. The left ovary is scarred into the sidewall and has a 4 Patientbelievesthatthissensationofpressure centimeter mass. You choose to remove that caused by something “falling out”(prolapse). ovary. Patients pain is unchanged but few weeks On pelvic exam there is no evidence of prolapse after laparoscopy patient develops additional and pain cannot be elicited with palpation. pain in the right lower quadrant. This area is tendertopalpationandpainisincreasedwith body movements.

58 Case scenario

Patient also notices cyclical sharp shooting pain in the left lower quadrant which was not present prior to surgery

PELVIC CONGESTION SYNDROME

Pelvic congestion syndrome Anatomy

• Complex network of venous structures • Plexie (plexuses) surround • Pelvic venous dilatation associated with rectum, bladder, vagina, reduced venous blood flow and leading to uterus, and ovaries pelvic pain • All interconnected by anastomoses • Pain is associated with decreased venous • Major drainage into return (standing, sitting, Valsalva) internal iliac system

Perry, 2006 Perry, 2006

Anatomy • Ovarian veins – Left into left renal vein • Normal caliber of – Right into vena cava ovarian veins • Absence of valves – – mean 3.8 mm 13‐15% left ovarian vein – 6% right ovarian vein – normal < 5mm • When valves are present – 7.5mm if incompetent – 43% left are incompetent valves – 35‐41% right are incompetent

Perry, 2006 Perry, 2006

59 Venous related pain syndromes Pain caused by varicosities

• Intraluminal pressure/distention • Blood flow • Varicocele in men • Ischemia in vessel • Varicose veins of the lower extremities • Ischemia in organs • Migraine headache • Venous stasis • Pelvic congestion syndrome • Venous outflow obstruction • Release of pain mediators

Perry, 2006

Numbers (renal donor) Numbers

• Incidence of congested veins – 10% • 80% of women without an obvious cause for • Incidence of pain if veins are congested – 59% their pain at laparoscopy have marked venous • Nephrectomy (obliteration of vein) congestion – Pain resolved – 54% • 91% of patients with chronic pelvic pain had – Pain improved – 23% evidence of varicocele compared with 11% of – Pain persistent – 23% patients without pain

Belenky et al.,2002 Beard et al.,1998

Predisposing factors Pathophysiology

Venous reflux estrogen Congenital or leading to progesterone acquired vein further vein pregnancy incompetence dilatation and • Parity valve failure • IUD placement ((ppcopper and hormonal)

Muscle spasm leading Fluid and • Uterine malposition (retroversion) to Valsalva voiding protein Nerve compression and increased decreased pH extravasation intraabdominal causing edema • Premenopausal (ovarian function) pressure

• Reduced External venous compression capillary flow causing hypoxia, inflammation and release of cytokines and tissue damage

Stones et al., 1994 Tu et al., 2010 Khan et al, 2000

60 Symptoms Symptoms

• Pain associated with prolonged standing or sitting • Pain brought on by increase in intra‐abdominal pressure (Valsalva) • Menstrual cycle defects – 54% • Postcoital dyspareunia 1‐2 days • Congestive dysmenorrhea – 66% • Sensation of heaviness in the pelvis / “something • Deep dyspareunia – 71% falling out” with occasional sharp shooting pain • Post coital ache – 65% • Predominantly unilateral L>R

Tu et al., 2010 Duncan & Taylor, 1952

Effect on other organs Exam

• Polycystic ovaries on ultrasound ‐ 56% • Tenderness with reproduction of pain with deep • Significantly increased uterine cross palpation over ovarian point sectional area (39. 1cm2 vs. 28.3 cm2) • Cervica l moti on ten dern ess • Endometrial thickness greater in pelvic • Blue cervical discoloration (venostasis) congestion (11.7mm vs. 8.3mm) • Retrocervical tenderness and paracervical tenderness

Adams et al., 1990 Beard et al.,1998

Exam Imaging

• Marked ovarian tenderness with gentle compression • Ultrasound reproducing pain • CT abdomen • Uterine tenderness • MRI abdomen • Transfundal venogram • Percutaneous venogram

Beard et al.,1998 Tu et al., 2010

61 Ultrasound with color Doppler Ultrasound with Valsalva

Computer Tomography Computer Tomography

Magnetic Resonance Retrograde flow

Enlarged vein Collateral circulation

Ovarian varicosity

Sophia Virani 2009 Beth Israel Deaconess Medical Center

62 Transfundal venography Diagnosis

112233

Ovarian vein 1‐4 mm 5‐8 mm >8 mm diameterdiameter

ClearanceClearanceof 0 s20 s40 s contrastcontrast

Ovarian plexus Normal Moderate Extensive congestioncongestion

Beard et al.,1998 Beard et al.,1998

Laparoscopy Diagnosis why not diagnostic

• Retroperitoneal position of veins • Increased intra‐abdominal pressure • Trendelenburg position • Negative laparoscopy  91% have pelvic congestion

Tu et al., 2010

Diagnosis Treatment

• Medical – Provera – GnRH agonist • Percutaneous – Embolization • Surgical – Ovarian vein ligation – Oophorectomy – Hysterectomy with BSO

Tu et al., 2010 Tu et al., 2010

63 Medical treatment Percutaneous treatment

Embolized vein

Sophia Virani 2009 Beth Israel Deaconess Medical Center Tu et al., 2010

Percutaneous ovarian vein Percutaneous treatment embolization

• Technical success 98 % of patients • 4% had migration of embolic agent • Total relief of symptoms – 58.5% • Moderate relief –9.7 %

Tu et al., 2010

Percutaneous treatment Surgical treatment

No of Ligation Follow up Cured Improved No change patients Edlundh 1964 6 short 6 Mattson 1936 25 1‐3 yrs 25 Metzger 20 0.5‐1.5 yrs 14 3 3 Miller 4 ? 4 Runquist 1984 15 0.5‐8 yrs 8 3 4 Sharp 1 7 yrs 1 Total 73% 17% 10% Embolization Edwards 1993 1 0.5 yrs 1 Giaccheti 1989 3 1 yr 3 Machan 23 2 yrs 16 Sichlau 1994 3 1 yr 2 1 6 Total 76% 3% 21% TAH/BSO Beard 1991 36 1 yr (24) 67% (12) 33% 0%

Tu et al., 2010 by Dr. DA Metzger

64 Selective pelvic vein ligation TFV –pre and post ligation

Colateral circulation Results

• 12/18 patients (67%) had improvement of pain at the postoperative visit • No worsening of pain • 8/12 patients had long term follow up (mean 24 month)hs) • 7 continued to have improvement of pain (3 pain free) • 1 patient pain returned ‐ cured with hysterectomy

Umeoka et al., 2004 Hibner AAGL 2011

Results

9 patients 18 patients Missing VAS

12 Pain 6 No improved improvement

4 Pain 1 Pain 3 Continued 4 Lost to F/U 3 Pain cured 3 Lost to F/U improved returned pain

Hysterectomy ABDOMINAL WALL NEURALGIAS Pain cured

Hibner AAGL 2011

65 Pelvic nerves3 Risk of nerve injury in gyn surgery

• Overall any neuropathy –1.9%

Lateral cutaneous • Obturator – 39%, branch of iliohypogastric nerve • Iliohypogastric Ilioinguinal/iliohypogastric – 21% Femoral branch of nerve genitofemoral nerve • Genitofemoral – 17% Genital branch of genitofemoral nerve Inferior rectal nerve • Femoral ‐ 7.5% Lateral femoral cutaneous nerve Posterior femoral cutaneous nerve • Lumbosacral plexus –0.2%

Clitoral/perineal Femoral nerve nerves • Overall recovery rate – 73% Cutaneous branch of obturator nerve

Hibner 2012 Honig, 2002

Ilioinguinal neuralgia Ilioinguinal neuralgia

• Burning numbing pain in the lower abdomen radiating to the (scrotum) • Compression of the ilioinguinal nerve as it • Worsened by lumbar extension passes through transverse abdominis muscle at the level of ASIS • Result of trauma or surgery

Eichenberger et al., 2006

Trocar placement Ilioinguinal/IH injury

• Ilioinguinal nerve – to ASIS • 3.1 cm medial • 3.7 cm inferior – to symphisis pubis • 2.7 cm lateral • Pfannenstiel incision –3.7% • 1.7 cm superior • Iliohypogastric nerve • TVT – 1.7% – to ASIS • 2.1 cm medial • Laparoscopic ports –? • 0.9 cm inferior – to symphisis pubis • Hernia repair ‐2% • 3.7 cm lateral • 5.2 cm superior

Whiteside et al., 2003 Whiteside et al., 2003

66 Trigger Point Injection Ilioinguinal neuralgia

Eichenberger et al., 2006 Eichenberger et al., 2006

Ilioinguinal neuralgia Treatment and Outcomes

• Sensory sparring – Nerve Blocks – 25% • Non‐Sensory Sparring – Alco ho l Ablat ion – 70% – Neurectomy – 87%

Loos et al. 2008

Genitofemoral neuralgia Genitofemoral neuralgia

• Symptoms similar to ilioinguinal neuralgia • Causes similar to ilioinguinal neuralgia – Placement of vena cava filter

Perry, 1997 Parris et al., 2010

67 Genitofemoral neuralgia

OVARIAN REMNANT SYNDROME

Ovarian remnant syndrome Risk factors

• Condition occurring in women who have had • Endometriosis oophrectomy with or without hysterectomy in • Adhesive disease whom some ovarian tissue was left behind • h/o PID • This residual tissue may eventually lead to • h/o appendicites pelvic mass and pain • h/o multiple previous surgeries

Magtibay & Magrina, 2006 Magtibay & Magrina, 2006

Presentation Hormonal status

• 84% ‐ continuous pelvic pain • 26% ‐ dyspareunia • 9% ‐ cyclic pelvic pain • 7% ‐ dysuria • 37% of patients have no symptoms of • 6% ‐ dyschezia estrogen deprivation despite not receiving ETR • 57% ‐ pelvic mass as presenting diagnosis but 93% of patient have pelvic mass on US or CT

Symmonds & Pettit, 1979 Magtibay et al., 2005

68 Hormonal assays Provocative testing

• Check hormones 10 days after stopping ERT • Estradiol <35mg/mL • FSH <30 • 70% of patients have premenopausal levels of • If remnant not seen on the ultrasound hormones – Clomiphene citrate 50 mg PO BID x 10 days • The likelihood of discovering ovarian remnant during – Repeat pelvic ultrasound surgical exploration increases when hormone values are premenopausal and patient is not on ERT

Magtibay et al., 2005 Kaminski et al., 1990

Medical therapy Radiotherapy

• Castrating dose – 1000 rads • Possibly helpful in 70% of patients • Oral contraceptives • Risk – Inconsistent results • Danazol – Injury to surrounding organs • GnRH agonists – • Progestagens • Should only be offered to patients with substantial surgical risk

Magtibay et al., 2005 Shemwell & Weed, 1970

Surgery Outcomes

• Open peritoneum lateral and parallel to ovarian vessels • Develop paravesical and pararectal spaces • Divide anterior division of the internal iliac artery • Identify ureter and ovarian vessels • Divide ovarian vessels above the pelvic brim • Remove entire pelvic sidewall peritoneum

Webb, 1989

69 Prevention of ovarian remnant Prevention of ovarian remnant

• Prevention of ovarian remnant is much easier than removing ovarian remnant later • When removing ovary – Open peritoneum lateral and parallel to the IP ligament • Do not remove the ovary: – Wide ly open the retroperitoneum – without opening retroperitoneum – Identify ovarian vessels and ureter – Make incision in peritoneum between the ureter and – by retracting ovary medially and ligating the ovarian vessels mesovarium with surgical staplers or endoloops – Ligate ovarian vessels far away from ovary – Remove ovary with surrounding peritoneum

Magtibay & Magrina, 2006 Magtibay & Magrina, 2006

References References

• Adams, J., Reginald, P. , Franks, S., Wadsworth, J., & Beard, R. (1990). Uterine size and endometrial thickness and the significance of cystic ovaries in women with pelvic pain due to congestion. BJOG, 97, 583–587. • Belenky, A., Bartal, G., & Atar, E. (2002). Ovarian Varices in Healthy Female Kidney Donors: Incidence, Morbidity and Clinical • Perry, C. P. (2006). Current concepts of pelvic congestion and chronic pelvic pain. JSLS 5(2), 105–10. Outcome. AJR 179(September), 625–627. • Perry, C. P. (1997). Laparoscopic treatment of genitofemoral neuralgia. JMIG 4(2), 231–4 • Beard, R., Reginald, P. , & Wadsworth, J. (1998). Clinical features of women with chronic lower abdominal pain and pelvic • Parris, D., Fischbein, N., Mackey, S., & Carroll, I. (2010). A novel CT‐guided transpsoas approach to diagnostic genitofemoral congestion. BJOG, 95, 153–161. nerve block and ablation. Pain Medicine, 11(5), 785–9. • Duncan, C. H., & Taylor, H. C. (1952). A psychosomatic study of pelvic congestion. AJOG, 64 • Shemwell, R., & Weed, J. C. (1970). Ovarian Remnant Syndrome. Obstetrics & Gynecology, 36(2), 299–303. • Eichenberger, U., Greher, M., Kirchmair, L., Curatolo, M., & Moriggl, B. (2006). Ultrasound‐guided blocks of the ilioinguinal • Stones, R., Beard, R., & Burnstock, G. (1994). Pharmacology of the human ovarian vein: responses to putative and iliohypogastric nerve: accuracy of a selective new technique confirmed by anatomical dissection. British Journal of neurotransmitters and endothelin‐1. BJOG, 101(8), 701–706. Anaesthesia, 97(2), 238–43 • Symmonds, R. E. & Pettit, P. D. (1979). Ovarian Remanant Syndrome. Obstetrics and Gynecology, 54(2), 174–177 • Honig, J. (2002). Postoperative neuropathies after major pelvic surgery. Obstetrics and Gynecology, 100(5 Pt 1), 1041–2 • Tu, F. F., Hahn, D., & Steege, J. F. (2010). Pelvic congestion syndrome‐associated pelvic pain: a systematic review of diagnosis • Kaminski, P. , Sorosky, J., Mandell, M. J., Broadstreet, R. P. , & Zaino, R. J. (1990). Clomiphene citrate stimulation as an adjunct and management. Obstetrical & Gynecological Survey, 65(5), 332–40. in locating ovarian tissue in ovarian remnant syndrome. Obstetrics & Gynecology, 76(5), 924–926. • Umeoka, S., Koyama, T., Togashi, K., Kobayashi, H., & Akuta, K. (2004). Vascular dilatation in the pelvis: identification with CT • Khan, a a, Eid, R. a, & Hamdi, a. (2000). Structural changes in the tunica intima of varicose veins: a histopathological and and MR imaging. Radiographics 24(1), 193–208. ultrastructural study. Pathology, 32(4), 253–7. • Webb, M. J. (1989). Ovarian remnant syndrome. The Australian & New Zealand Journal of Obstetrics & Gynaecology, 29(4), • Magtibay, P. M. & Magrina, J. F. (2006). Ovarian remnant syndrome. Clinical Obstetrics and Gynecology, 49(3), 526–34. 433–5. • Magtibay, P. M., Nyholm, J. L., Hernandez, J. L., & Podratz, K. C. (2005). Ovarian remnant syndrome. AJOG 193(6), 2062–6 • Whiteside, J. L., Barber, M. D., Walters, M. D., & Falcone, T. (2003). Anatomy of ilioinguinal and iliohypogastric nerves in • Loos, M. J. a, Scheltinga, M. R. M., & Roumen, R. M. H. (2008). Surgical management of inguinal neuralgia after a low relation to trocar placement and low transverse incisions. AJOG, 189(6), 1574–1578. transverse Pfannenstiel incision. Annals of Surgery, 248(5), 880–5

70 CHRONIC PELVIC PAIN As we understand it today • Consultant: Ethicon Women's Health & Urology • Speaker's Bureau: Abbott Laboratories Fred M. Howard, MS, MD Professor Emeritus of Obstetrics‐Gynecology University of Rochester School of Medicine & Dentistry Rochester, New York [email protected]

1 OBJECTIVES CASE

• Identify several of the major differences between • 38 y.o. WG2P2002 with CPP x 8‐10 yrs visceral & somatic pain • Hx Laparoscopy, 1998, endometriosis • List the mechanisms important in the – pathophysiology of CPP Decreased pain x 10 mos • Assess t he clin ica l siifiignificance of • Hx LSO , 2002, endometrioma – Windup – No change in pain – Central sensitization • Referred for LSH, 2004 – Peripheral sensitization – CPP, dysmenorrhea, dyspareunia VAS 7‐10 – Antidromic transmission – Neuroplasticity

2 3 CASE CASE

• Cyclical, painful postop • Recurrent pain without bleeding • Rx OCPs • US showed probable endometrioma – BTB and persistent pain • Trachelectomy & RSO, 2006 • Rx Norethindrone acetate, 5 mg/d – Endometrioma – Amenorrhea • Persistent pain, VAS 0‐8 – Decreased pain, VAS 2‐5 – Dyspareunia VAS 8 • D/C NE 2006 – Vaginal apex allodynia – Wt gain – New onset urinary frequency & nocturia

71 4 CASE Why review this case?

• Potassium test positive •Dx of endometriosis associated pelvic pain – Pentosan polysulfate sodium • Not cured by several appropriate surgical procedures – Ranitidine • HRT: estradiol & testosterone • Not relieved by hormonal therapy • Pain management initiated • Developed bladder symptoms later – Amitriptyline • Dx as IC/PBS – Hydrocodone‐actaminophen – Ondansetron • Inadequate pain relief by medical treatment of IC/PBS – VAS 1‐7, Avg VAS 5 • Multimodal pain management • 2011 –same multimodal treatment – Fully functional • Is a very common type of history with CPP

Visceral vs Somatic PATHOPHYSIOLOGY OF PAIN Sources of Abdominopelvic Pain • Somatic vs Visceral • Visceral – Reproductive organs • Nociceptive vs Inflammatory vs Neuropathic – Gastrointestinal tract – Urinary tract – Peritoneum • Somatic – Muscles – Fascia – Peritoneum – Subcutaneous tissue – Skeletal system

VISCERAL NOCICEPTION Innervation of Pelvic Viscera: General

• Overlap of pathways of different viscera • Nociceptors – Silent nociceptors – Multiple viscera converge onto same spinal cord neurons – Low concentration of nociceptors (viscerovisceral convergence) • 2 ‐ 10% of all afferents to the spinal cord • Makes localization of visceral pain difficult • NiNoxious stimu li – Distention – Ischemia – Hemorrhage – Referral from other viscera – Inflammation – Traction of mesentery

72 Innervation of Pelvic Viscera: General

• Overlap of pathways of different viscera – Multiple viscera converge onto same spinal cord neurons (viscerovisceral convergence) – There are dichotomous or dichotomizing visceral afferent nerves

Innervation of Pelvic Viscera: General

• Overlap of pathways of different viscera – Multiple viscera converge onto same spinal cord neurons (viscerovisceral convergence) – There are dichotomous or dichotomizing visceral afferent nerves – Makes identification & localization of visceral pain difficult

Innervation of Pelvic Viscera: General Classification of Visceral Pain

• Overlap of pathways of different viscera • True visceral pain – Multiple viscera converge onto same spinal cord neurons (viscerovisceral convergence) • Referred pain without hyperalgesia – There are dichotomous or dichotomizing visceral afferent nerves – Makes identification & localization of visceral pain difficult • Referred pain with hyperalgesia • OlOverlap of pathways with somatic stttructures – Viscerosomatic convergence – Results in referred pain – Development of cutaneous or deep tissue hyperalgesia • Does not differ significantly from hyperalgesia secondary to skin or muscle injury – Viscerosomatic convergence

73 Referred Visceral Pain w/ Hyperalgesia Referred Visceral Pain w/ Hyperalgesia

• Pain in somatic areas that are metamerically connected to the affected viscus • Secondary hyperalgesia – PiPain thres ho ld is dddecreased • Muscles in area in state of sustained contraction T10 –L2 – Possible cause of trigger points with chronic visceral pain?

PATHOPHYSIOLOGY OF PAIN PAIN MECHANISMS Definition of Nociceptive Pain

• Visceral • Somatic • Pain in response to a noxious stimulus that – Nociceptive – Nociceptive – Inflammatory alerts the organism to impending tissue injury – Inflammatory – Neuropathic – Acts as an early warning system by announcing – Neuropathic – Psyygchogenic the presence of stimuli that could damage normal – Psychogenic – Mixed – Mixed tissue – Idiopathic – Idiopathic • “Normal pain” • “Physiologic pain”

Steps in Nociception Treatment of Nociceptive Pain

• Disease‐specific – Nociceptive

Abbott J et al. Fertil Steril 2004;82:878-84

74 Approaches to Treatment Approaches to Treatment

• Disease‐specific • Disease‐specific – Nociceptive – Nociceptive • PiPain‐specific • PiPain‐specific – Nociceptive – Nociceptive

Intravesical lidocaine Presacral neurectomy IC/PBS Endometriosis

Parsons. UROLOGY 2005; 65: 45–48. Zullo et al. Am J Obstet Gynecol 2003;189:5-10

Approaches to Treatment Approaches to Treatment

• Disease‐specific • Disease‐specific – Nociceptive – Nociceptive • PiPain‐specific • PiPain‐specific – Nociceptive – Nociceptive

Opioid analgesics Cognitive-behavioral therapy Visceral pain syndrome Pelvic congestion syndrome

Rabkin & Howard, unpublished data Farquhar CM, et al. Br J Obstet Gynaecol 1989;96:1153-62

Definition of Inflammatory Pain Inflammatory Pain

Pain in response to tissue injury and the • Inflammatory response is physiologic resulting inflammatory process – Promotes healing • Inflammation may affect neuronal function • With chronic inflammation inflammatory mediators bind to receptors on pain‐transmitting neurons & alter their function – Increase excitability (allodynia) – Increase pain sensation (hyperalgesia) – May enhance peripheral sensitization

75 VISCERAL NOXIOUS STIMULI Inflammation & Visceral Pain

• Hemorrhage • One of the important effects of inflammatory pain is the activation of ‘‘silent nociceptors’’ • Infection • Many nociceptors in viscera are silent nociceptors • Inflammation – Silent nociceptors do not normally respond to mechanical or thermal • Neoplasm stimuli – With inflammation of the surrounding tissue, they become sensitized • Distention of and respond to pressure, distension, or heat – Hollow viscus • May be important with endometriosis & IC/PBS which are – Capsule of solid viscus inflammatory disorders • Traction of mesentery of viscus

Gebhart GF. J.J. Bonica Lecture 2000: Physiology, pathophysiology,and pharmacology of visceral pain. Reg Anesth Pain Med. 2000;25:632–638.

VISCEROSOMATIC HYPERALGESIA Approaches to Treatment Cutaneous receptive field with colonic distention to 80 mm Hg • Disease‐specific – Nociceptive With repetitive distention • PiPain‐specific – Nociceptive – Inflammatory After irritation of the colon with turpentine Rofecoxib Endometriosis

Ness & Gebhart Cobellis et al. Euro J Obstet Gynecol Reprod Biol 2004;116:100–102

NEUROPATHIC PAIN NEUROPATHIC PAIN

• Post herpetic neuralgia Pain produced by damage to or dysfunction of • Complex regional pain syndrome neurons in the peripheral or central nervous • Phantom limb pain system • Entrapment neuropathy • Peripheral neuropathy – Diabetes – Chronic alcohol use • Becomes independent of inciting event – Toxins – Vitamin deficiencies • Sustains chronic pain state • Endometriosis • IC/PBS • IBS

76 Important Terms Wind‐up

• Windup Progressive increase in the amplitude of • Central sensitization electrical response of the dorsal horn neurons • Peripheral sensitization with repetitive stimulation of a peripheral • Antidromic transmission nociceptor • Neuroplasticity

VISCERAL HYPERALGESIA Central Sensitization

• Increased excitability of central pain‐ VAS rating with transmitting neurons repeated colonic • Manifests as distention – Reduction in pain threshold (allodynia) – Increased response to painful stimuli (hyperalgesia) – Increased duration of pain after nociceptor stimulation (persistent pain)

Ness et al. Pain 1990;43:377-386.

CENTRAL SENSITIZATION Central Sensitization ENDOMETRIOSIS

As-Sanie S, Kim JH, Clauw DJ. SGI 2009 (Scotland) (unpublished data)

77 Peripheral Sensitization Peripheral Sensitization

• Increase in excitability of peripheral • Often mediated by an inflammatory process nociceptors • Causes increased pain signaling to the spinal cord • Amplifies pain silignals to the centra l nervous • In effect, it turns up t he vo lume o f pa in siilgnals system relayed to spinal cord neurons – The patient feels more pain – Results in increased pain sensation

Peripheral Sensitization Antidromic Transmission

• Probably due to prolonged generation of pain signals • Can establish a pathologic dorsal root reflex • Afferent dorsal horn cells release mediators that cause action potentials to fire antidromically

Clinical Correlation Antidromic Transmission Neuroplasticity • Enhanced peripheral sensitization • The nervous system’s ability to reorganize itself by forming new neural connections – Peripheral tissues more painful than normal – Compensate for injury or disease • Allodynia – Adjust in response to new situations or changes • Hyperalgesia • Mechanism ‐ “Axonal sppgrouting" • Possible referred “trigger points” – Undamaged axons grow new nerve endings to reconnect neurons whose links were injured or severed – Undamaged axons sprout nerve endings & connect with other undamaged nerve cells to form new neural pathways to accomplish a needed function

78 INNERVATION OF ENDOMETRIOSIS DIFFERENCES IN MYOMETRIAL INNERVATION

100

80

60 Endo % CPP 40 No CPP

20

0 Microneuromas Perivasc n prolif

Atwal et al. Amer J Obstet Gynecol 2005;193:1650–5 Berkley et al. PNAS 2004; 101: 11094-8

DIFFERENCES IN MYOMETRIAL INNERVATION Psychogenic Pain

• Pain disorder associated with psychological Endo CPP No CPP factors • Pain that is mostly related to psychological factors

N fibers/0.5 mm3 32 22 12

Definition of Mixed Pain

Pain that results from any combination of nociceptive, inflammatory, neuropathic and So…..Can we answer some of the clinical psychogenic mechanisms conundrums that we see every day in Probably most cases of CPP our clinical practices?

79 Co‐occurrence of Diagnoses in CPP

Diagnosis Endo IC/PBS IBS VVS

Endo 18% 32% 31% 18%

IC/PBS 38% 6% 28% 28%

IBS 41% 31% 6% 24%

VVS 26% 36% 27% 7%

Droz & Howard. JMIG 2011; 18:211-7.

Central Sensitization – Central Sensitization Antidromic Transmission

80 REFERENCES Approaches to Treatment • Abbott J et al. Fertil Steril 2004;82:878‐84 • Parsons. UROLOGY 2005; 65: 45–48. • Zullo et al. Am J Obstet Gynecol 2003;189:5‐10 • Farquhar CM, et al. Br J Obstet Gynaecol 1989;96:1153‐62 • Disease‐specific • Gebhart GF. J.J. Bonica Lecture 2000: Physiology, pathophysiology,and – Nociceptive pharmacology of visceral pain. Reg Anesth Pain Med. 2000;25:632–638. • Cobellis et al. Euro J Obstet Gynecol Reprod Biol 2004;116:100–102 • PiPain‐specific • Ness et al. Pain 1990;43:377‐386. – Nociceptive • As‐Sanie S, Kim JH, Clauw DJ. SGI 2009 (Scotland) (unpublished data) – Inflammatory • Berkley et al. PNAS 2004; 101: 11094‐8 – Neuropathic • Atwal et al. Amer J Obstet Gynecol 2005;193:1650–5 • Droz & Howard. JMIG 2011; 18:211‐7 • Howard FM. Endometriosis and mechanisms of pelvic pain. J Minimally Invasive Gynecol 2009; 16: 540‐50

81 CULTURAL AND LINGUISTIC COMPETENCY

Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians (researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

US Population California Language Spoken at Home Language Spoken at Home

Spanish English Spanish

Indo-Euro English Indo-Euro Asian Other Asian

Other 19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the program, the importance of the services, and the resources available to the recipient, including the mix of oral and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies, including those which provide federal financial assistance, to examine the services they provide, identify any need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every California state agency which either provides information to, or has contact with, the public to provide bilingual interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills. A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

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