2/5/2016
ABS Complications
Anal Slings-investigational
Similar to transvaginal tape or transobturator tape for UI Dacron, mersilene, polyester, and teflon mesh, fascia lata WWdiftiiound infections, sinus ttltract, ulcer Treated with antibiotics or removal Used in conjunction with tx for rectal prolapse
TRANSFORM Study ClinicalTrials.gov Identifier: NCT01090739 TOPAS (AMS) sling for FI Prospective, multi-multi-center(12center(12 sites) SingleSingle--arm,arm, openopen--label,label, twotwo--stage,stage, adaptive study with one planned interim analysis Primary outcome 1414--dayday bowel diarydiary--50%50% reduction FI episodes N=152N=152 The mesh sling placed via the transobturator approach
Mellgren A, et al. Am J Obstet Gynecol, 2015.
13 2/5/2016
Primary Outcome 50% reduction in the number of FI episodes from baseline to 12 months postpost--operativelyoperatively on a 14 day bowel diary. Secondary Outcomes Decrease in Fecal Incontinent Days and Urge Episodes Symptom Severity: Cleveland Clinic Incontinence Scores Quality of Life: Fecal Incontinence Quality of Life (FIQOL) Safety
SurgerySurgery
SurgerySurgery
14 2/5/2016
SurgerySurgery
DEMOGRAPHICS
Age (years) 59.6 ± 9.7 BMI (kg/m²) 27.8 ± 5.4 Ethnicity White/Caucasian 137 (90.1%) Black or African American 10 (6.6%)
American Indian/First Nations 0 (0%)
Asian 1 (0.7%) Hispanic/Latina 3 (2.0%)
Native Hawaiian/Pacific Islander 0 (%)(0%)
Other 1 (0.7%) Obstetric History Parity 2.6 ± 1.4 # of vaginal deliveries 2.4 ± 1.5 Menopausal Status Pre-menopausal 20 (13.2%) Peri-menopausal 6 (3.9%) Post-menopausal 126 (82.9%) Continuous Variables are mean ± SD; Categorical variables are N (%)
SurgerySurgery
Mean surgical time = 33 minutes (range 1111--71)71) Mean EBL = 13 cc (range 00--50)50) Mean hospital stay = 11 hours (2(2--57)57) NO visceral injuries or perforations
15 2/5/2016
Primary Outcome-Outcome-1212 months
Sustained OutcomesOutcomes--3434 months
Secondary Outcomes
Baseline 12 mos. P value Median (range) Median (range)
CCIS (Wexner) 13.9 (mean) 9.6 (mean) < 0.001 FI Episodes per 9.0 (2-40.5) 2.0 (0-40) < 0.001 week FI Incontinent Days 5.0 (1.5-7) 2.0 (0-7) < 0.001
FI with Urgency 2.0 (0-7) 0 (0-26) < 0.001
16 2/5/2016
Improvement in FIQOL
P<0.05 for all domains
Treatment Related Adverse Events
Number of Number of Patients Adverse Event Category Events (% Patients) Pelvic pain 47 41 (27.0%) Infection 26 22 (14.5%) Incision site infection 9 9 (5.9%) Abscess 2 2 (1.3%) Other infection problem 17 no treatment15 14 (9.2%) Urinary problems 6 6 (3.9%) Worsenin29g urinar treatedy incontinence with 2medical 2 (()1.3%thera) py Other urinary problem 4 4 (2.6%) Pelvic organ prolapse 1 sciatica8 surgery6 (3.9%) Pelvic organ prolapse (de novo) 4 3 (2.0%) Pelvic organ prolapse10 (worsening) persistent 4 at 1 year3 (2.0%) Bleeding 1 1 (0.7%) DefecatoryNone dysfunction classified as2 SAEs2 (1.3%) by FDA Other 14 14 (9.2%) Total standards104 66 (43.4%)
NO mesh erosions or extrusions
Surgical/Other Procedural Treatments for Fecal Incontinence
Refractory to multi- component treatment
Anal Sphincter Repair
Other procedures/surgical interventions
SECCA Neuromodulation Posterior/Percutaneous Tibial Artificial sphincter Nerve Stimulation Hyaluronate Sodium Anal Sling- investigational Magnetic Anal Sphincter-invest, Myoblast-investigational Refractory to All
Colostomy
17 2/5/2016
Radiofrequency Therapy: SECCA®
SECCA® Efficacy Data
Long-term* (5 year) study, mean Wexner incontinence score improved from 14 to 8, p<0.0003 80% subjects had 50% improvement N=19 OtherO studies limited by short-term follow-upf and small sample sizes (N=8-50) No comparative data Main AEs rectal bleeding and pain
*Takahashi-Monroy et al, 2008
PTNS-targets sacral plexus
18 2/5/2016
Posterior Tibial Nerve Stimulation
Peripheral neuromodulation directed to L4-S3 nerve roots Spppleen 6 point in Chinese acupuncture OAB, UUI, pelvic/bladder pain, impotence
RCT with sham effective for OAB/Urge UI
PTNS
The largest prospective study including 115 patients with a median follow-up of 26 months (range, 12 – 42) reported 52% of patients achieving a ≥ 50% reduction in FI episodes as well as improving QOL* First multi-center RCT (the CONtrol of Faecal Incontinence using Distal NeuromoulaTion [CONFIDeNT]) in the United Kingdom was recently published This trial included 227 patients to evaluate the efficacy and cost- effectiveness of PTNS (n=115) comparing to sham electrical stimulation (n=112) Interestingly, the study reported no difference between the PTNS and sham groups in efficacy at 12 weeks: 38% in PTNS versus 31% in sham achieving a ≥50% reduction in the number of FI episodes per week, adjusted ratio 1.28 (95%CI 0.72-2.28; p=0.40) **
*Hoturas et al, 2014; **Knowles, 2015
Non Animal Sodium Hyaluronate-NASHA Dx
Dextranomer microspheres and sodium hyaluronic acid Identical to Deflux
Administered via anoscope to the proximal anal canal Out-patient setting No anesthesia Four 1ml blebs of Solesta
19 2/5/2016
Solesta: Pivotal Trial
Only large scale trial in the literature – injectable bulking agent vs. sham 206 patients 13 sites in U.S. and EU 80% female Three part primary endpoint Superiority over sham at 6 months Threshold responder rate at 6 months Durability of effect to 12 months
Graf et al, Lancet, 2011
Solesta Pivotal Trial: Results
All 3 success criteria were met Responder rates superior to sham at 6 months Above the predetermined threshold
Durability of effect out to 12 months: 57.4% Responder50
80
60 (%) (%) p=0.004 50 53.2% 40
20 30.7%
0
oportion responders Solesta Sham r
Most Common Related AEs - Solesta Patients Pivotal Study Through 18 Months
Preferred term Events % patients Proctalgia 41 17.3 Injection site hemorrhage 18 8.1
Rectal hemorrhage 15 7.6 Pyrexia 14 6.6 Injection site pain 10 5.1 Diarrhea 10 4.1 Anal hemorrhage 9 4.1 Anorectal discomfort 8 4.1 Rectal discharge 7 3.6 Proctitis 5 2.5
Majority of AE’s were mild and self limited
20 2/5/2016
Magnetic Anal SphincterSphincter--InvestigationalInvestigational
-Fenix™ -series of titanium beads with magnetic cores linked together with independent titanium wires -to defecate, the force generated by straining separates the beads to open up the anal canal -the technique of implantation is simple with no requirement of adjustments
18 subjects (15 women) underwent MAS, f/u 353-738 days CCIS decreased from 17.5 (14-20) to 7.3 (0-12), all domains of FIQOL improved 76% subjects ≥50% reduction FI episodes/w Pakravan F, Helmes C . Dis Colon Rectum, 2015
Autologous Myoblast Injection-Investigational
Injection of autologous myoblast injection can potentially replace or repair damaged sphincter tissue and enhance function Animal model studies being performed Myogenic stem cell studies also being performed
Carr et al, 2013, Carr et al, 2008, Frudinger etal, 2010, Montoya et al, 2015
Final Consideration
Fecal Diversion
21 2/5/2016
Fecal Diversion
Considered “last resort” One case-control and two cohort studies Results in improved QOL More cost effective at 5 years than artificial AS and dynamic graciloplasty Usually an end sigmoid colostomy without proctectomy (rectal stump)) Laparoscopic approach, safe and effective
Colquhoun et al, 2006; Norton et al, 2005;Ludwig et al, 1996
Question
Treatments for fecal incontinence that are considered investigational include all of the following except:
A. Fenix titanium beads
B. Non-animal sodium hyaluronate
C. Posterior tibial nerve stimulation
D. TOPAS peri-anal sling
Question
Treatments for fecal incontinence that are considered investigational include all of the following except:
A. Fenix titanium beads
B. Non-animal sodium hyaluronate
C. Posterior tibial nerve stimulation
D. TOPAS peri-anal sling
22 2/5/2016
Conclusions
Cause of fecal incontinence is often multi-factorial 1st line treatment is… Education Pelvic Floor Muscle Exercises Medications Normalization Of Stool Consistency Bowel Habits Devices*Devices* Surgery helpful for many women Need to be able to discuss all options with patients and individualize care
Conclusions
Sphincteroplasty has reasonable shortshort--termterm but reduced longlong--termterm results Neuromodulation therapy helps those with refractory FI Other therapies needed-recent data on devices; need RCTs! Individualization of treatment
Things could always be worse…….
23 2/5/2016
Select References
National Institute for Health and Clinical Excellence (2007). Faecal Incontinence: The Management of Faecal Incontinence in Adults. Clinical guideline No. 49. NICE, London
RemesRemes--TrocheTroche JM, Rao SSC. Neurophysiological testing in anorectaldisorders. Expert Rev Gastroenterol Hepatol 2008;2:323--335335 2008;2:323
Omotosho TB, Rogers RG. Evaluation and Treatment of Anal Incontinence, Constipation, and DefecatoryDefecatory Dysfunction. ObstetObstet GynecolGynecol ClinClin NAmNAmN Am 2009;36:6732009;36:673--697697
Hayden DM, Weiss EG. Fecal Incontinence: Etiology, Evaluation, and Treatment. Clin Colon Rectal Surg2011;24:64- 2011;24:64-7070
Rao SSC. Advances in diagnostic assessment of fecal incontinence and dyssynergic defecation. Clin Gastroenterol Hepatol 2010;8:910--919.e2919.e2 2010;8:910
Gurland B, Hull T. Transrectal Ultrasound, ManometryManometry,, and Pudendal Nerve Terminal Latency Studies in the Evaluation of Sphincter Injuries. Clin Colon Rectal Surg2008;21:157--166166 2008;21:157
Select References
Halland M, Talley NJ. Fecal incontinence: mechanisms and management. Curr Opin Gastroenterol 2012;28:57-62
Lacy BE, Weiser. Common Anorectal Disorders: Diagnosis and Treatment. Curr Gastroenterol Rep 2009;11:413-419
Mellgren A. Fecal Incontinence. Surg Clin N Am 2010;90:185-194
Shah BJ, Chokhavatia S , Rose S. Fecal Incontinence in the Elderly: FAQ. Am J Gastroenterol 2012;107:1635-1646
Meyer I, Richter HE. Impact of Fecal Incontinence and It’s Treatment on Quality of Life. Women’s Health 2015; 11:225-38
Whitehead WE, Rao SSC, Lowery A, et al. Treatment of Fecal Incontinence: State of the Science Summary for the National Institute of Diabetes and Digestive and Kidney Diseases Workshop. Am J Gastroenterol 2015; 110: 138- 46
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