UPDATE

PELVIC FLOOR DYSFUNCTION Bowel management for the gynecologist

›› Michael R. Polin, MD ›› Cindy L. Amundsen, MD Dr. Polin is Fellow, Female Dr. Amundsen is Professor Pelvic Medicine and and Female Pelvic Medicine Reconstructive , and Reconstructive Surgery and Clinical Instructor, Fellowship Director, Obstetrics and Gynecology, Department of Obstetrics Department of Obstetrics and Gynecology, at Duke and Gynecology, at Duke University. University in Durham, North Carolina.

Dr. Polin reports no financial relationships relevant to this article. Dr. Amundsen reports that she receives grant or research support from the National Institutes of Health.

onstipation is estimated to affect up to The diagnosis of is based C27% of the general population and is more on the Rome III criteria.2 Besides frequency common in women, with a 2:1 female-to-male of bowel movements (BMs), these criteria ratio.1 Because gynecologists are frequently include evacuation symptoms and the pres- the main care provider for many women, ence of hard stools (TABLE 1). These symp- IN THIS ARTICLE understanding the diagnosis and treatment toms can result from delay in colonic transit options for constipation is important. Addi- or outlet dysfunction. Constipation may be Evaluation algorithm tionally, gynecologists must manage bowel secondary to medical illness, such as central for chronic function during the perioperative period. or peripheral neurologic disease, diabetes constipation Page 19 TABLE 1 Rome III criteria for TABLE 2 Common treatments functional constipation in adults* for constipation Probiotics: trend or 1. Must include ≥2 of the following signs Bulk-forming laxatives absorb water, increas- valid treatment? or symptoms: ing fecal mass Page 25 • Straining during ≥25% of defecations • psyllium seed (Metamucil) • Lumpy or hard stools in ≥25% of • methylcellulose (Citrucel) defecations • calcium polycarbophil (FiberCon) Bowel prep for • Sensation of incomplete evacuation for • wheat Dextran (Benefiber) vaginal surgery ≥25% of defecations Surfactant agents lower the surface tension of • Sensation of anorectal obstruction/ Page e1 stool, allowing water to enter the stool blockage for ≥25% of defecations • Manual maneuvers to facilitate ≥25% of • docusate sodium (Colace) defecations (ie, digital evacuation, Osmotic laxatives contain poorly/nonabsorbed support of the ) substances, leading to intestinal water secretion • <3 defecations per week • polyethylene glycol (MiraLAX) 2. Loose stools are rarely present without • magnesium citrate (Milk of Magnesia) the use of laxatives Stimulant laxatives increase colonic transit and alter electrolyte transport across the colonic 3. Insufficient criteria for irritable bowel syndrome mucosa • bisacodyl (Dulcolax) *At least 3 months, with symptoms beginning ≥6 months before diagnosis. • senna (Senokot)

18 OBG Management | November 2014 | Vol. 26 No. 11 obgmanagement.com mellitus, hypothyroidism, or medications. In this article, we review the results of Evaluation begins with a careful history and randomized trials comparing the efficacy of vaginal and perianal/anal examination.3 Ini- OTC medical treatments for constipation, tially, a trial of fiber supplementation with including daily, low-dose polyethylene gly- or without over-the-counter (OTC) laxatives col (PEG) and probiotics. Additionally, we may be tried (TABLE 2). If patients have an review key trials evaluating perioperative inadequate response to this therapy, further bowel management prior to laparoscopic evaluation may be pursued (ALGORITHM). gynecologic and vaginal surgery.

Evaluation algorithm for chronic constipation

Interview and physical examination

Consider metabolic and structural evaluation, baseline labs

Therapeutic trial of fiber ± laxatives

Inadequate response

If patients have Anorectal manometry and balloon expulsion test an inadequate response to fiber supplementation with or without Normal Inconclusive Abnormal over-the-counter laxatives, further evaluation may be pursued Colonic Barium or MR Defecatory transit defecography disorder

Slow Normal Normal Abnormal

Slow transit Normal transit constipation constipation

Adapted from American Gastroenterological Association medical position statement on constipation.3 CONTINUED ON PAGE 24

obgmanagement.com Vol. 26 No. 11 | November 2014 | OBG Management 19 UPDATE pelvic floor dysfunction

CONTINUED FROM PAGE 19 Long-term PEG usage safe and effective?

Corazziari E, Badiali D, Bazzocchi G, et al. Long-term measurements between the two groups. Of efficacy, safety, and tolerability of low daily doses of the PMF-100 group, 70% completed the study, isosmotic polyethylene glycol electrolyte balanced solu- compared with 30% of the placebo group tion (PMF-100) in the treatment of functional chronic (P<.01). Nonresponse to treatment was the constipation. Gut. 2000;46(4):522–526. reason for dropout in 7% and 46% of patients, respectively (P<.005). Other causes of with- drawal did not differ between the groups. n this multicenter, randomized, double- At the end of the 20 weeks, 77% of Iblind, placebo-controlled, parallel trial, patients in the PMF-100 group reported investigators evaluated the safety, efficacy, remission, compared with 20% in the pla- and tolerability of a daily low-dose PEG- cebo group (P<.001). During the study, the based osmotic diuretic. PMF-100 group reported more BMs per week (7.4 vs 4.3; P<.001). Furthermore, the treat- Details of the study ment group was less likely to report straining Seventy-eight patients (80% of them female) at defecation, hard/pellet stools, and need aged 18 to 75 years with chronic constipa- for use of additional laxatives. Adverse events tion, defined by Rome III diagnostic criteria, (nausea, anal pain/itching, hematochezia, underwent a 4-week “run-in” period, with epigastric pain, and ) were a standardized daily diet of fiber 15 g, water similar between groups. There were no differ- 1500 mL, and twice-daily PMF-100 (PEG/ ences in laboratory values. osmotic solution). Patients were random- Low-dose ized if they responded to the regimen, with Study strengths polyethylene response defined as having at least two BMs This was a well-designed trial showing the glycol/osmotic per week and no defecatory disturbance or safety, efficacy, and tolerability of a daily low- solution resulted at least three BMs per week with or without dose PEG-based osmotic diuretic. The popu- in constipation defecatory disturbance. Eight patients were lation was mainly women with functional remission in 77% not randomized, one due to nonresponsive- chronic constipation, similar to a gynecologic ness. Study patients completed 20 weeks population. The results of this trial are consis- of patients of either twice-daily PMF-100 or placebo. tent with what has been shown for other trials Patients, at their own discretion, decreased evaluating various PEG preparations.4,5 the frequency of the study drug based on the frequency of their BMs. Use of another WHAT THIS EVIDENCE laxative was not allowed unless a BM had not MEANS FOR PRACTICE occurred over a 5-day period. The combined primary outcome was Women who fail initial fiber therapy may re- at least three BMs per week, no defecatory spond to daily low-dose PEG on a continu- disturbances, and no additional laxative ous basis. Resolution of constipation and use. Secondary outcomes (frequency of BMs defecatory symptoms is likely and should and defecatory disturbances) were assessed be seen within 1 month. Therapy can be using a bowel diary. continued safely for at least 6 months. No differences were noted in baseline

CONTINUED ON PAGE 25

24 OBG Management | November 2014 | Vol. 26 No. 11 obgmanagement.com UPDATE pelvic floor dysfunction

CONTINUED FROM PAGE 24 New and trendy OTC treatment option

Del Piano M, Carmagnola S, Anderloni A, et al. The However, both probiotic preparations resulted use of probiotics in healthy volunteers with evacuation in increased bowel frequency by day 30 (5.3 disorders and hard stools: a double-blind, random- vs 7.3 BMs per week for probiotic A [P<.001] ized, placebo-controlled study. J Clin Gastroenterol. and 5.8 vs 6.9 BMs per week for probiotic B 2010;44(suppl 1):S30–S34. [P<.001]). When comparing each probiotic with the placebo at days 15 and 30, a statistically signif- actors such as age, unhealthy diet, and icant increase in bowel frequency was found Fuse of prescription drugs alter the intes- with each probiotic preparation. Furthermore, tinal bacterial flora. As patients strive for a all secondary outcomes improved during the more holistic approach to their health, inter- 30 days with the probiotic preparations but est is growing in the benefit of probiotics for not the placebo. There was a statistically sig- treating chronic constipation. To explore the nificant improvement in these variables when value of such probiotics, Del Piano and col- either probiotic was compared with placebo. leagues conducted a three-armed, random- No adverse events were reported. ized, double-blind placebo-controlled trial of two different probiotic preparations and a Strengths and limitations placebo among patients aged 24 to 71 years This randomized, double-blind, placebo- with evacuation disorders and constipation. controlled trial showed improvement in bowel frequency, based on a bowel diary, Details of the study with two different probiotic preparations One probiotic preparation (A) was composed when compared with placebo. The study of Lactobacillus plantarum and Bifidobacte- population did not have to meet Rome III rium breve at a concentration of 2.5×109 cfu criteria for constipation, and baseline fre- Two different per day; the other (B) was composed of quency of BMs was high. Patients did report probiotic Bifidobacterium animalis subspecies lactis subjective improvement in their defecatory preparations 9 at a concentration of 5×10 cfu per day. symptoms with both probiotic preparations, significantly Patients took their preparation for 30 days but use of validated questionnaires would increased bowel and recorded data on weekly defecations have strengthened this finding. movement frequency (primary outcome), along with feces consis- within 30 days tency, ease of expulsion, sensation emptying, WHAT THIS EVIDENCE compared with anal itching/burning/pain with defecation, MEANS FOR PRACTICE placebo and abdominal bloating (secondary out- comes). Patients with mild constipation and def- A total of 300 patients were enrolled in ecatory complaints may benefit from the the study; 50% were female. No difference was addition of a probiotic preparation. How- noted in baseline symptoms among the three ever, more thorough studies need to be groups. No change from baseline was noted performed to characterize the true extent in BMs per week within the placebo group of probiotics’ benefits. during the 30 days (5.6 vs 5.8, respectively).

CONTINUED ON PAGE 26

obgmanagement.com Vol. 26 No. 11 | November 2014 | OBG Management 25 UPDATE pelvic floor dysfunction

CONTINUED FROM PAGE 25 Bowel prep before laparoscopic gynecologic surgery

Siedhoff MT, Clark LH, Hobbs KA, Findley AD, Mould- the two groups. Analysis was on an intent- er JK, Garrett JM. Mechanic bowel preparation before to-treat basis, but only two patients did not laparoscopic hysterectomy: a randomized controlled complete the bowel preparation. Overall, the trial. Obstet Gynecol. 2014;123(3):562–567. study population had a mean age of 41 and body mass index of 33.5 kg/m2. No differ- ences were noted in surgical characteristics ver the past decade, extrapolation of between the two groups, including com- Odata from colorectal surgery litera- plication rate. The mean surgery time was ture, showing no benefit from preoperative 139 minutes with a mean estimated blood loss mechanical bowel preparation,6 has led to of 61 mL and a mean uterine weight of 385 g. less frequent use of mechanical bowel prepa- The surgeon’s assessment of the- sur rations for open benign gynecologic surgery. gical field did not differ between the two Nevertheless, there has been slower adoption groups. This finding also held true when sub- of this practice with laparoscopic and vaginal group analysis was performed for obesity, surgery. In a recent study, Siedhoff and col- endometriosis, irritable bowel syndrome or leagues explored surgeons’ assessments of inflammatory bowel disease, and chronic surgical field exposure in patients who did constipation. Interestingly, the odds of the and did not complete preoperative mechani- surgeon guessing whether a patient had had cal bowel preparation. a preparation were 50:50. The only differ- ence in patient symptoms was an increase in Bowel preparation Details of the study insomnia in the no-preparation group. did not lead to This was a single-masked, randomized, con- significant between- trolled trial involving women undergoing Minor drawback group differences laparoscopic hysterectomy for benign indi- This well-performed trial demonstrated in this young study cations. Patients were randomly assigned to no significant value for mechanical bowel population (mean either a sodium phosphate enema the night preparation before benign laparoscopic before surgery and, if their stool was not hysterectomy in a young population. How age, 41 years) clear, another enema on the morning of sur- these results might extrapolate to an older gery versus no preparation. All patients had population who may have a higher rate of clear liquids the day prior to surgery, then prior pelvic surgery or diverticular disease is fasted beginning at midnight. The surgeon uncertain. was blinded to the randomization. The primary outcome was a question- naire completed by the surgeon that assessed WHAT THIS EVIDENCE surgical field exposure. Secondarily, patients MEANS FOR PRACTICE completed a questionnaire addressing symp- Women undergoing laparoscopic hyster- toms (cramps, hunger, bloating, embarrass- ectomy for a benign indication may forego ment, insomnia, weakness, dizziness, thirst, a mechanical bowel preparation as such nausea, and incontinence). preparation did not improve the surgical Baseline characteristics of the 160 ran- field. domized patients did not differ between

CONTINUED ON PAGE e1

26 OBG Management | November 2014 | Vol. 26 No. 11 obgmanagement.com UPDATE pelvic floor dysfunction

CONTINUED FROM PAGE 26 Bowel prep before vaginal surgery

Ballard AC, Parker-Autry CY, Markland AD, Varner bowel preparation compared with 90% in RE, Huisingh C, Richter HE. Bowel preparation before the no-preparation group (P = .3). Addition- vaginal prolapse surgery: a randomized controlled ally, no difference was noted in the presence trial. Obstet Gynecol. 2014;123(2 pt 1):232–238. of rectal stool or gas by inspection and pal- pation. Patient satisfaction was significantly lower among those who underwent bowel n this single-masked, randomized con- preparation compared with patients who did Itrolled trial in women undergoing recon- not. Patients undergoing bowel preparation structive vaginal prolapse surgery, Ballard were more likely to have abdominal fullness and colleagues randomly assigned patients or bloating (P = .004), abdominal cramps or to either a clear liquid diet with two saline pain (P<.001), anal irritation (P<.001), and enemas the day before surgery or a regular hunger pains (P<.001). diet the day before surgery. Prep group saw no benefit Details of the study and decreased satisfaction All 150 patients were instructed to fast begin- This well-performed clinical trial showed ning at midnight the night before surgery, that the use of mechanical bowel preparation and the surgeon was blinded to randomiza- did not significantly improve surgeons’ intra- tion. The study’s primary outcome was the operative acceptability of the operative field surgeon’s perception of the operative field during vaginal prolapse surgery. However, assessed by a questionnaire. The secondary approximately 25% of patients underwent outcome was the patient’s satisfaction with sacrospinous suspensions; therefore, intra- their preoperative regimen as reported on peritoneal access was not necessary in these validated questionnaires. patients. The study results demonstrated Bowel preparation An intent-to-treat analysis was performed decreased patient satisfaction and more dis- led to decreased (mean age, 60 years); 84% of patients assigned tressing bowel symptoms in patients who patient satisfaction to bowel preparation completed more than underwent a mechanical bowel preparation and increased 50% of the enemas. Baseline characteristics with an enema. likeliness of and surgical procedures were similar between WHAT THIS EVIDENCE abdominal bloating, groups. Approximately 33% of patients under- MEANS FOR PRACTICE cramps, or pain; went hysterectomy concomitantly with the anal irritation; and prolapse repair. Operative time, estimated Use of a mechanical bowel preparation hunger pains blood loss, and bowel injury were similar is not necessary to improve the surgical between the two groups. field in vaginal prolapse surgery. Not hav- No difference between groups was noted ing patients undergo a bowel preparation in the surgeons’ assessment of the surgi- will improve patients’ assessment of their cal field—which was rated as excellent or preparation for surgery. good in 85% of patients who underwent the

References 1. Higgins PD, Johanson JF. Epidemiology of constipation in 4. American College of Gastroenterology Chronic Constipation North America: a systematic review. Am J Gastroenterol. Task Force. An evidence-based approach to the management 2004;99(4):750–759. of chronic constipation in North America. Am J Gastroen- 2. Longstreth GF, Thompson WG, Chey WD, Houghton LA, terol. 2005;100(suppl 1):S1–S22. Mearin F, Spiller RC. Functional bowel disorders. Gastroen- 5. Ramkumar D, Rao SS. Efficacy and safety of traditional medi- terology. 2006;130(5):1480–1491. cal therapies for chronic constipation: systematic review. Am 3. Bharucha AE, Dorn SD, Lembo A, Pressman A. American J Gastroenterol. 2005;100(4):936–971. Gastroenterological Association medical position state- 6. Guenaga KF, Matos D, Wille-Jørgensen P. Mechanical bowel ment on constipation. Gastroenterology. 2013;144(1): preparation for elective colorectal surgery. Cochrane Data- 211–217. base Syst Rev. 2011;(9):CD001544.

obgmanagement.com Vol. 26 No. 11 | November 2014 | OBG Management e1