Faculty Scholarship

Objective:  To assess the efficacy and comparative effectiveness of surgical and nonsurgical treatments for fecal incontinence (FI) in adults. 

Data sources: Ovid MEDLINE®, Embase®, PEDro®, CINAHL®, AMED, and the Cochrane Central Register of Controlled Trials (CENTRAL); hand searches of systematic reviews. 

 Methods: Two investigators screened abstracts of identified references for eligibility (examined treatments in adults with FI published from 1980 to the present that had a control/comparator group; case series were included for surgical interventions). Full-text articles were reviewed to identify patient-reported outcomes (FI episodes, FI severity, quality of life, urgency, pain, other). We extracted data, assessed risk of bias of individual studies, and evaluated strength of evidence for each comparison and outcome.

 Results:  Sixty-three unique studies met inclusion criteria; an additional 53 surgical case series were examined for adverse effects. Enrolled adults were mostly female with mixed FI etiologies. Most randomized controlled trials (RCTs) were nonsurgical (n = 38); 13 examined pelvic floor muscle training (PFMT) and PFMT with biofeedback (PFMT-BF). Meta-analysis was not possible because numerous outcomes were used. Low-strength evidence suggests that dietary fiber (psyllium) decreases FI episodes (-2.5 per week) at 1 month; clonidine has no effect; and PFMT-BF with electrostimulation is no more effective than PFMT-BF for FI severity and the FI Quality of Life scale (FIQL) over 2 to 3 months. Low-strength evidence at 6 months suggests that dextranomer anal bulking injections are more effective than sham injections on the FIQL, the number of FI-free days, and the percent of adults with at least 50-percent reduction from baseline in FI episodes, but no more effective than PFMT-BF with or without electrostimulation on FI severity (PFMT-BF -5.4 vs. dextranomer -4.6 point Vaizey score improvements) and the FIQL, and no more effective than sham injection on FI severity (-2.5 vs. -1.7 point sham improvement in Cleveland Clinic FI score [CCFIS]) or FI episode frequency. Moderate-strength evidence suggests that Durasphere® (off label) bulking injections reduce FI severity up to 6 months (-4 to -5 points CCFIS), but gains diminish thereafter. Evidence was insufficient for all other surgical and nonsurgical comparisons. Surgical improvements varied. Noninvasive nonsurgical treatments had few minor adverse effects (AEs). Surgical treatments were associated with more frequent and more severe complications than nonsurgical interventions. AEs were most frequent for the artificial bowel sphincter (22–100% of adults). Surgical AEs ranged from minor to major (infection, bowel obstruction, perforation, fistula). Major surgical complications often required reoperation; fewer required permanent colostomy. Only 12 percent of RCTs were high quality.   

Conclusion: We found limited evidence to support any FI treatments beyond 3 to 6 months. Comparing the effectiveness of FI surgical and nonsurgical treatments is difficult because nonsurgical approaches generally precede surgery. Most current interventions show modest improvements in FI outcomes that meet minimal important differences (MIDs) in the short term, where MID is known. More invasive surgical procedures have substantial complications.

Background: No systematic review has examined the collective randomized and nonrandomized evidence for fecal incontinence treatment effectiveness across the range of surgical treatments.

Objective: The purpose of this study was to assess the efficacy, comparative effectiveness, and harms of surgical treatments for fecal incontinence in adults.

Data sources: Ovid MEDLINE, EMBASE, Physiotherapy Evidence Database, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine, and the Cochrane Central Register of Controlled Trials, as well as hand searches of systematic reviews, were used as data sources.

Study selection: Two investigators screened abstracts for eligibility (surgical treatment of fecal incontinence in adults, published 1980-2015, randomized controlled trial or observational study with comparator; case series were included for adverse effects). Full-text articles were reviewed for patient-reported outcomes. We extracted data, assessed study risk of bias, and evaluated strength of evidence for each treatment-outcome combination.

Interventions: Surgical treatments for fecal incontinence were included interventions.

Main outcome measures: Fecal incontinence episodes/severity, quality of life, urgency, and pain were measured.

Results: Twenty-two studies met inclusion criteria (13 randomized trials and 9 observational trials); 53 case series were included for harms. Most patients were middle-aged women with mixed FI etiologies. Intervention and outcome heterogeneity precluded meta-analysis. Evidence was insufficient for all of the surgical comparisons. Few studies examined the same comparisons; no studies were high quality. Functional improvements varied; some authors excluded those patients with complications or lost to follow-up from analyses. Complications ranged from minor to major (infection, bowel obstruction, perforation, and fistula) and were most frequent after the artificial bowel sphincter (22%-100%). Major surgical complications often required reoperation; few required permanent colostomy.

Limitations: Most evidence is intermediate term, with small patient samples and substantial methodologic limitations.

Conclusions: Evidence was insufficient to support clinical or policy decisions for any surgical treatments for fecal incontinence in adults. More invasive surgical procedures had substantial complications. The lack of compliance with study reporting standards is a modifiable impediment in the field. Future studies should focus on longer-term outcomes and attempt to identify subgroups of adults who might benefit from specific procedures.