Fecal incontinence (FI) is characterized by the frequency of episodes and the consistency of the feces.1–3 FI severity varies widely. The negative psychological effects, social stigma, and reduced quality of life surrounding FI can be devastating for affected adults.3
In individual adults, multiple causes of FI are common, and a dominant etiology may not be determinable. Risk factors for FI include older age, female sex, anal sphincter injury, obstetrical trauma, chronic diarrhea, nerve damage, postsurgical or postradiation complications, cognitive impairment, and other factors, such as severe constipation.4,5
Treatment goals are to decrease the frequency and severity of FI episodes, and the multiple contributing factors of FIs often necessitate a combination of treatments. Most treatments are aimed at symptom reduction; few treatments, if any, afford long-term cures for FI. FI treatments typically progress from easy-to-implement nonsurgical treatments (dietary fiber or drugs) to more intensive (pelvic floor muscle training with biofeedback) or invasive nonsurgical (anal sphincter tissue bulking injections) to surgical treatments. Surgery is typically considered after other approaches have failed. Nonsurgical treatments may also be used to complement surgical treatment. Not all treatments are appropriate for all patients, because FI etiologies and other patient factors dictate feasible treatment options.1
Nonsurgical treatments include dietary fiber supplementation,5 stool-modifying drugs,6 pelvic floor muscle training with biofeedback,7,8 anal plugs,9,10 rectal irrigation,10,11 or combinations thereof.5,7 More invasive injections of biocompatible tissue-bulking agents into the anal canal walls may also be used,12 and other nonsurgical interventions are emerging.13,14 Surgical procedures used to treat FI in the United States include sacral nerve stimulation (SNS), radiofrequency anal sphincter remodeling, antegrade colonic enema (ACE), sphincteroplasty, sphincter replacement, surgical correction of conditions that can result in FI (rectal prolapse, hemorrhoids, or rectocele), or, when all other treatments fail, colostomy.1,5,15–17
This review seeks to increase the breadth and use of the review findings to better inform clinical decision making and research needs. Although many recent systematic reviews have assessed the effectiveness of surgery or SNS for FI using randomized clinical trials (RCTs),15–21 no systematic review has examined the collective randomized and nonrandomized evidence for FI treatment effectiveness across the range of surgical treatments. Given the heterogeneous population of adults afflicted with FI, this review included observational studies with control groups to encompass a broader range of patients and prognostic variables that are often unavailable from limited RCT samples. Case series were included for harms information that is typically limited in small surgical RCTs. Our review addressed the following 2 questions:
- 1) What is the comparative effectiveness of surgical treatments to improve quality of life and continence and lessen the severity of FI in affected adults?
- 2) What adverse effects are associated with specific surgical treatments for adults with FI?
PATIENTS AND METHODS
Our a priori review protocol is posted on the Effective Health Care Program Web site (http://www.effectivehealthcare.ahrq.gov/) of the Agency for Healthcare Research and Quality. Bibliographic database searches identified RCTs and observational studies published from 1980 to June 2015 on treatments for adults with FI from Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Central Register of Controlled Trials, Ovid Physiotherapy Evidence Database, and Allied and Complementary Medicine. Appendix Table 1 contains our Medline search strategy, which was modified for other databases. We also hand-searched reference lists of related systematic reviews published since 2007. Grey literature searches were also conducted.
Studies were selected based on the Population, Intervention, Comparator, Outcomes, Timing, and Setting framework and on the inclusion criteria in Appendix Table 2. Two investigators independently reviewed titles and abstracts for FI surgical treatment studies with at least 1 patient-centered outcome. Citations deemed potentially eligible by either investigator underwent full-text screening. Differences in screening decisions were resolved by consultation with a third investigator. We extracted data into evidence tables by the type of study design. Initial data abstraction was quality checked by a second investigator.
Individual study risk of bias (study quality) was assessed by 2 independent investigators using instruments specific to each study design; discrepancies were reconciled with a third investigator. We used a modified Cochrane risk-of-bias tool22 for RCTs and an instrument for observational studies based on the Observational Studies Risk of Bias and Precision Item Bank by Research Triangle Inc.23 Each study was assigned an overall summary risk-of-bias rating of low, moderate, or high based on the collective risk of bias inherent in each domain.24
Strength-of-evidence assessment was based on 5 domains:25 1) risk of bias/study limitations (internal validity), 2) directness (link between the intervention and outcome), 3) consistency (effect direction and magnitude), 4) precision (degree of certainty around an estimate), and 5) reporting bias. The possible strength-of-evidence grades25 ranged from high to insufficient (evidence is unavailable or does not permit a conclusion). To assign a grade of low strength of evidence rather than insufficient, we required at least 2 moderate risk of bias studies or 1 sufficiently powered, low risk-of-bias RCT for a specific treatment–outcome comparison. We graded strength of evidence for treatment–outcome combinations that assessed FI severity/impact or quality of life in studies with low or moderate risk of bias; literature comparisons that were unavailable or did not meet this evidence quality minimum were labeled as insufficient evidence on which to draw conclusions about treatment-versus-comparator effectiveness on a specific outcome.
Meta-analysis was not possible because of intervention and outcome heterogeneity. This review was funded by Agency for Healthcare Research and Quality under the US Department of Health and Human Services.26
We identified 2978 unique citations (Appendix Fig. 1) from all of the databases combined. Of those, 22 studies met inclusion criteria, 13 RCTs and 9 observational studies with comparators; 53 case series were also included for adverse effects. Because of variability in follow-up, we considered evidence as short term (if <3 months27–29), intermediate term (3–6 months30–36), or long term (>6 months31–33,36–39).
We included 13 surgical RCTs (Table 1) and 9 observational studies with comparison groups (Table 2) that assessed the comparative effectiveness of surgical treatments to lessen the severity of FI or to improve quality of life. The average age of enrolled adults was 55 to 65 years in 75% of surgical RCTs. Of adults enrolled in the 12 surgical RCTs that reported patient sex (Table 1), 95% were women. Eleven RCTs (85%) and 4 observational studies with comparison groups (44%) enrolled 40 or fewer adults (Table 1). Nearly two thirds (62%) of RCTs and 56% of observational studies enrolled adults with mixed FI etiologies.
All of the included RCTs and observational studies had moderate- or high-risk of bias (Appendices 3 and 4), indicating that study quality was low. In addition, few studies examined the same interventions. Given these 2 important weaknesses, the resulting strength-of-evidence ratings were insufficient for all of the surgical interventions.
Sacral Nerve Stimulation
Five crossover RCTs examined SNS, mostly in 55- to 60-year–old women with mixed FI etiologies (Table 1). The evidence for SNS was insufficient because all 5 of the studies had moderate27,36 or high28,29,35 risk of bias, and none assessed the same treatment–outcome combination. Brief RCT summaries are below; details are provided in Table 1 and Appendix Table 3.
The RCTs compared the SNS versus supportive medical care on FI outcomes <1 year.36 Authors reported significant within-group improvements in Cleveland Clinic Fecal Incontinence Score (CCFIS), FI episodes, and Fecal Incontinence Quality of Life with SNS in a single, unblinded RCT. Not all of the collected outcomes were reported, outcomes were assessed by the investigators, and between-group statistical comparisons were not conducted.
RCTs also compared the effects of leaving the SNS stimulator on versus off for 1 month on FI frequency and the CCFIS.29 There was no significant difference in CCFIS improvement between on versus off periods; graphical FI episode counts were not usable.
Stimulation at 75% or 50% of sensory threshold versus stimulation at sensory threshold (ST) in adults using SNS for ≥3 months at study enrollment was also compared.27 No significant change in CCFIS, Vaizey score, or other FI functional outcomes occurred across SNS settings; the Fecal Incontinence Quality of Life coping subscale improved at sensory threshold only.
High-frequency, low, or prolonged pulse width stimulation to regain efficacy in persons with sustained loss of efficacy after chronic stimulation was compared.35 The CCFIS modestly improved (–2.4 to –2.7 points) during the 4-week RCT segments with high frequency or prolonged pulse width stimulation, but no other outcomes were significantly or meaningfully improved.
Finally, turning stimulation off versus leaving it on at night on FI outcomes was compared.28 The CCFIS and Vaizey scores were 1 point worse during the off at night period in a crossover study without any washout period, and no baseline values were reported for any outcome measure.
Two high risk-of-bias observational studies (Table 2 and Appendix Table 4) provided insufficient evidence for SNS versus sphincteroplasty40 and for open versus percutaneous SNS lead placement.41 Follow-up between groups differed by >2 years in both studies (Table 2).
Anal sphincter repair was examined in 2 RCTs31,37 and 5 observational studies.40,42–45 There was insufficient RCT evidence (Table 1) to compare the effectiveness of sphincter repair with stoma/fecal diversion versus sphincter repair alone37 from 1 high risk-of-bias RCT that assessed CCFIS changes from baseline anywhere from 16 to 47 months postoperatively and did not report mean follow-up by group (Table 1). There was also insufficient RCT evidence to compare the effectiveness of adjuvant biofeedback after anal sphincter repair versus sphincter repair alone31 in 1 high risk-of-bias RCT. Improvements in CCFIS, Fecal Incontinence Quality of Life subscale, and patient satisfaction were not significantly different by group. Authors excluded postrandomization data from 18% of the sample (Table 1).
Observational studies (Table 2) provided insufficient evidence to compare the effectiveness of a perineal versus posterior fourchette incision in overlapping anal sphincter repair,42 sphincteroplasty with pelvic floor repair versus sphincteroplasty,43 sphincteroplasty versus SNS,40 sphincteroplasty versus anterior levatorplasty,44 and direct versus anterior sphincter repair.45 Four40,43–45 of these 5 studies had high risk of bias (Appendix Table 4).
Anal Sphincter Replacement
Given the strength of evidence grading criteria listed in the Patients and Methods section above, evidence was insufficient to compare the effectiveness of an artificial bowel sphincter (ABS) versus conservative medical management from 1 high risk-of-bias RCT of 14 patients with severe FI32 (Table 1 and Appendix Table 3) and from 1 high risk-of-bias observational study of a non-US Food and Drug Administration–approved magnetic anal sphincter versus an ABS46 (Table 2 and Appendix Table 4).
Other Surgeries and Mixed Treatment Comparisons
Evidence was also insufficient to compare the effectiveness of total pelvic floor repair versus gluteus maximus transposition without electrical stimulation for postobstetric neuropathic FI,38 postanal repair versus total pelvic floor repair for neurogenic FI,34 and total pelvic floor repair versus anterior levatorplasty versus postanal repair for neurogenic FI39 (Table 1).
For mixed treatments, evidence was insufficient for levatorplasty versus nonsurgical anal plug electrostimulation33 from 1 high risk-of-bias RCT, with differential losses to follow-up by group (13% vs 25%) and exclusion of noncompleters from the analysis (Table 1); for nonsurgical percutaneous posterior tibial nerve stimulation compared with SNS30 that excluded 23% of postrandomization data from the analysis(Table 1); and for the magnetic anal sphincter versus SNS,47 where follow-up differed by 16 months between groups (Table 2).
Evidence was insufficient for recommendations after failed sphincteroplasty.13 Only 1 high risk-of-bias observational study compared the outcomes of 3 surgical treatments used in adults who had failed at least 1 previous sphincteroplasty13 (Table 2).
Adverse effects from surgical treatments were reported in 8 RCTs (Table 3), 8 observational studies with comparators (Table 4), and 53 case series (Appendix Table 5). Surgical complications were common and ranged from minor (eg, swelling or hematoma) to major (eg, infection, bowel obstruction, perforation, or fistula); major complications often required reoperation; some required a permanent colostomy. Notably, we found only case series studies for radiofrequency anal sphincter remodeling and antegrade colonic irrigation (ACE) in adults.
The frequency of surgical complications (Tables 3 and 4 and Appendix Table 5) ranged from 0% to 32% in radiofrequency anal sphincter remodeling,48–53 21% to 74% in ACE,54–57 5% to 27% with sphincteroplasty,13,37,42–45,58–66 2% to 93% with SNS,13,29,30,36,41,47,67–85 8% to 64% with other surgeries,33,38,39,86 and 22% to 100% with sphincter replacement.13,32,46,87–100
The severity of adverse effects varied by the type of surgery (Tables 3 and 4 and Appendix Table 5). Adverse effects were generally less severe for radiofrequency anal sphincter remodeling (pain, bleeding, swelling, and mucosal ulceration) and SNS (infection, pain, electrode/lead issues, and device malfunction). However, SNS required reoperation in 3% to 41% of patients for device-related complications (Table 4 and Appendix Table 5), and 3% to 24%41,47,67–69,71,72,74–81,85 of patients had the device explanted. ACE, sphincter repair, and sphincter replacement had more severe complications (wound infection, stenosis, bowel obstruction, sepsis, and fistula; Appendix Table 5). The most frequent and severe complications occurred with the ABS; infections were very common, and 14% to 81% of recipients underwent surgical explant of the device; some patients required permanent colostomy.13,32,46,87–100
As determined using standard quality assessment criteria, the evidence for surgical treatment effectiveness for FI in adults is insufficient for all surgical interventions. Few surgical procedures were examined in RCTs or observational studies with comparison groups; study aims and treatments were highly varied, and all of the surgical studies had moderate to high risk of bias. The overwhelming majority (71%) of surgical studies reviewed were case series, which provide low-quality research evidence. We were unable to conduct a meta-analysis, because few studies examined the same treatment–outcome combination within similar timeframes, and outcome measures varied. Thus, the literature provides little guidance for surgeons and patients in their selection of surgical treatments for FI.
Study conduct and reporting were often inconsistent with longstanding Consolidated Standards of Reporting Trials (CONSORT) recommendations,101–103 thereby diminishing support for individual study conclusions (Appendix Tables 3 and 4).
Case series of some procedures, such as ACE and sphincter replacement, showed that complications may occur months after surgery (Appendix Table 5). The severity of complications increased with the invasiveness of the treatment. Complications from ACE, sphincteroplasty, and sphincter replacement were most severe; SNS complications were less severe, but all of these treatments may require additional major or minor surgery.
Findings in Relationship to What Is Already Known
We examined the range of surgical treatments available for FI in adults in the United States and included randomized and nonrandomized literature. In contrast, previous systematic reviews examined evidence within single modes of FI treatment, such as surgery or SNS,15,17,18,104 and relied primarily on RCT evidence for adverse effects. Similar to our findings, other systematic reviews found weak evidence for most procedures and similar literature limitations (small number of studies, small patient samples, and substantial methodologic limitations), leaving little definitive evidence in support of specific surgical procedures for FI. However, this review adds substantial information on postoperative complications that is not available from previous systematic reviews.
We compared our findings with recent FI treatment guidelines from 2 professional societies, the American College of Gastroenterology105 and the American Society of Colon and Rectal Surgeons106 (Appendix Table 6). None of the surgical recommendations by the American Society of Colon and Rectal Surgeons or American College of Gastroenterology are supported by the findings of this review. There is general agreement about the weak strength of the evidence but variation in the actions recommended in the face of this situation. One example of this discrepancy is in recommendations for the ABS (Appendix Table 6). The American Society of Colon and Rectal Surgeons gave the ABS a strong (favorable) recommendation,106 yet noted that the evidence for that opinion was of low or very low quality. In contrast, the American College of Gastroenterology identified the ABS evidence as insufficient105 and gave it a weak recommendation105; our review also found the evidence about ABS to be insufficient to enable conclusions about the effectiveness of ABS. Colorectal surgeons more strongly favored surgical approaches than did the gastroenterologists; both groups supported SNS, which had insufficient evidence in this review.
Limitations of the evidence base compose the majority of limitations of this review. The evidence base would benefit from better compliance with CONSORT101 and greater efforts to avoid compromising study integrity by analyzing only a subset of randomized adults. Also, although FI is a chronic problem, most surgical evidence of treatment benefits is intermediate term; high-quality, longer-term information would better inform clinical decisions. In addition, common outcome measures need to be standardized. The same scoring system was often referenced by several names. The Vaizey score (0–24107) was sometimes labeled as “St. Mark’s” (0–13108),27,28,35 and the CCFIS109 was labeled as CCFIS, Wexner, or Jorge/Wexner. More information about typical patient demographics, clinical features, and status at enrollment would better inform about which treatments work best in which patients. Information on cointerventions was also limited. More uniformity in how FI episodes are defined and severity graded would improve comparability across studies; clinicians and patients may disagree on FI severity ratings.110 Input from adults with FI may help to identify and quantify aspects of FI that capture outcomes most important to patients, such as urgency. Multiple etiologies may contribute to FI; perhaps as a result, etiologies were variably reported in the literature. No study provided information about the frequency of multiple FI etiologies per adult at baseline, such as summary counts per patient or common etiologic/risk factor combinations.
There are several limitations related to the review process. As stated above, meta-analysis was not possible because treatment–outcome combinations varied. Although this review was limited to English-language publications, the possibility of missing clinical trials of US Food and Drug Administration–approved procedures is remote.111,112 We did not contact authors for clarification of indeterminable information.
Three steps could advance FI research quality: 1) conduct and report clinical research that in accordance with CONSORT criteria; 2) establish academic research/clinical centers to facilitate a more structured, multidisciplinary team approach to research question development and study design; and 3) enhance patient input into outcome measure development. Validated outcome measures that capture the FI impact features most meaningful to patients (eg, urgency and severity) are critical to advance the field.
Funding mechanisms, such as the P01 or P50 program grants from the National Institutes of Health, could support these clinical research activities. Such centers could be regional centers that do high-volume work in FI or research centers that coordinate multicenter studies, providing strong research designs and assuring fidelity to treatment.
Few if any treatments can entirely cure FI; therefore, information on treatment combinations would benefit the evidence base. More work is needed to determine which additional interventions should be undertaken postoperatively and when they should be initiated to enhance or prolong the durability of surgical benefits.
The sustainability of surgical treatment effects over time deserves more attention. Longer-term studies were largely case series of subsets of adults who underwent procedures and had extended follow-up, leaving many questions about adults who underwent the same procedures but were not included in reporting.
The degree of external anal sphincter defect that impacts the outcome of SNS is unclear. Older studies excluded patients with extensive tears; more recent observational studies found that adults with extensive tears improve with SNS <1 year.113,114
There is limited information about the results of treatments chosen after failed index surgical procedures.13 Better comparison of the benefit:harm ratio of FI treatments is needed, especially for invasive surgical interventions. Substantial and life-altering adverse events occur after FI surgery, and these were underidentified in RCTs.
Implications for Clinical and Policy Decision Making
The current FI literature lacks high-quality research evidence to inform clinical practice or policy. These findings differ from professional society guidelines in several key areas; these groups may wish to re-evaluate treatment recommendations based on weak or insufficient evidence and revise such guidelines. Given the clinical complexity of many adults with FI, potential new centers that could generate better research evidence and manage patients in multidisciplinary settings may be the next best step to advance both research and patient care.
The quality of the FI surgical evidence is insufficient for clinical decision making. Substantial methodologic and reporting issues can be rectified by following current study and reporting standards; small improvements could provide higher-quality evidence. The use of numerous outcome measures impedes the field. The overall strength of evidence for treatments for FI in adults was insufficient, suggesting that future studies with higher quality evidence could change the conclusions of this review.
1. International Continence Society. Faecal incontinence: ICS fact sheets. http://www.ics.org/Documents/Documents.aspx?FolderID=82
. Accessed April 18, 2014.
2. Whitehead WE, Borrud L, Goode PS, et al. Fecal incontinence
in US adults: epidemiology and risk factors. Gastroenterology. 2009;137:512517, e511e512.
3. NIH state-of-the-science conference statement on prevention of fecal and urinary incontinence in adults. NIH Consens State Sci Statements. 2007;24:137.
4. Shamliyan T, Wyman J, Bliss DZ, Kane RL, Wilt TJ. Prevention of urinary and fecal incontinence
in adults. Evid Rep/Technol Assess. 2007;161:1379.
6. Omar MI, Alexander CE. Drug treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013;6:1CD002116.
7. Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev. 2012;7:CD002111.
8. Boyle R, Hay-Smith EJ, Cody JD, Mørkved S. Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2012;10:CD007471.
9. Deutekom M, Dobben AC. Plugs for containing faecal incontinence. Cochrane Database Syst Rev. 2012;4:CD005086.
10. Cazemier M, Felt-Bersma RJ, Mulder CJ. Anal plugs and retrograde colonic irrigation are helpful in fecal incontinence
or constipation. World J Gastroenterol. 2007;13:31013105.
11. Briel JW, Schouten WR, Vlot EA, Smits S, van Kessel I. Clinical value of colonic irrigation in patients with continence disturbances. Dis Colon Rectum. 1997;40:802805.
12. Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013;2:CD007959.
13. Hong KD, da Silva G, Wexner SD. What is the best option for failed sphincter repair? Colorectal Dis. 2014;16:298303.
14. Thomas GP, Dudding TC, Rahbour G, Nicholls RJ, Vaizey CJ. A review of posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. 2013;15:519526.
15. Brown SR, Wadhawan H, Nelson RL. Surgery
for faecal incontinence in adults. Cochrane Database Syst Rev. 2013;7:CD001757.
16. Fernando RJ, Sultan AH, Kettle C, Thakar R. Methods of repair for obstetric anal sphincter injury. Cochrane Database Syst Rev. 2013;12:CD002866.
17. Thaha MA, Abukar AA, Thin NN, Ramsanahie A, Knowles CH. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. 2015;8:CD004464.
18. Thin NN, Horrocks EJ, Hotouras A, et al. Systematic review
of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence. Br J Surg. 2013;100:14301447.
19. Hong KD, Dasilva G, Kalaskar SN, Chong Y, Wexner SD. Long-term outcomes of artificial bowel sphincter for fecal incontinence
: a systematic review
and meta-analysis. J Am Coll Surg. 2013;217:718725.
20. Ratto C, Litta F, Parello A, Donisi L, De Simone V, Zaccone G. Sacral nerve stimulation in faecal incontinence associated with an anal sphincter lesion: a systematic review
. Colorectal Dis. 2012;14:e297e304.
21. Glasgow SC, Lowry AC. Long-term outcomes of anal sphincter repair for fecal incontinence
: a systematic review
. Dis Colon Rectum. 2012;55:482490.
22. Higgins JP, Altman DG, Gøtzsche PC, et al.; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
23. Viswanathan M, Berkman ND. Development of the RTI item bank on risk of bias and precision of observational studies. J Clin Epidemiol. 2012;65:163178.
24. Viswanathan M, Ansari MT, Berkman ND, et al. Assessing the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions
. Rockville, MD: Agency for Healthcare Research and Quality; 2008.
25. Berkman ND, Lohr KN, Ansari M, et al. Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective Health Care Program of the Agency for Healthcare Research and Quality: An Update. MD: Agency for Healthcare Research and Quality; 2013.Rockville.
26. Forte ML, Andrade KE, Butler M, Lowry AC, Bliss DZ, Slavin JL, Kane RL. Treatments for Fecal Incontinence
: Comparative Effectiveness Review No. 165. March 2016. Rockville, MD: Agency for Healthcare Research and Quality.
27. Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S. Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study. Ann Surg. 2013;257:219223.
28. Michelsen HB, Krogh K, Buntzen S, Laurberg S. A prospective, randomized study: switch off the sacral nerve stimulator during the night? Dis Colon Rectum. 2008;51:538540.
29. Leroi AM, Parc Y, Lehur PA, et al.; Study Group. Efficacy of sacral nerve stimulation for fecal incontinence
: results of a multicenter double-blind crossover study. Ann Surg. 2005;242:662669.
30. Thin NN, Taylor SJ, Bremner SA, et al.; Neuromodulation Trial Study Group. Randomized clinical trial of sacral versus percutaneous tibial nerve stimulation in patients with faecal incontinence. Br J Surg. 2015;102:349358.
31. Davis KJ, Kumar D, Poloniecki J. Adjuvant biofeedback following anal sphincter repair: a randomized study. Aliment Pharmacol Ther. 2004;20:539549.
32. O’Brien PE, Dixon JB, Skinner S, Laurie C, Khera A, Fonda D. A prospective, randomized, controlled clinical trial of placement of the artificial bowel sphincter (acticon neosphincter) for the control of fecal incontinence
. Dis Colon Rectum. 2004;47:18521860.
33. Osterberg A, Edebol Eeg-Olofsson K, Hålldén M, Graf W. Randomized clinical trial comparing conservative and surgical treatment of neurogenic faecal incontinence. Br J Surg. 2004;91:11311137.
34. van Tets WF, Kuijpers JH. Pelvic floor procedures produce no consistent changes in anatomy or physiology. Dis Colon Rectum. 1998;41:365369.
35. Duelund-Jakobsen J, Dudding T, Bradshaw E, et al. Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence. Br J Surg. 2012;99:14451452.
36. Tjandra JJ, Chan MK, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence
: a randomized, controlled study. Dis Colon Rectum. 2008;51:494502.
37. Hasegawa H, Yoshioka K, Keighley MR. Randomized trial of fecal diversion for sphincter repair. Dis Colon Rectum. 2000;43:961965.
38. Yoshioka K, Ogunbiyi OA, Keighley MR. A pilot study of total pelvic floor repair or gluteus maximus transposition for postobstetric neuropathic fecal incontinence
. Dis Colon Rectum. 1999;42:252257.
39. Deen KI, Oya M, Ortiz J, Keighley MR. Randomized trial comparing three forms of pelvic floor repair for neuropathic faecal incontinence. Br J Surg. 1993;80:794798.
40. Ratto C, Litta F, Parello A, Donisi L, Doglietto GB. Sacral nerve stimulation is a valid approach in fecal incontinence
due to sphincter lesions when compared to sphincter repair. Dis Colon Rectum. 2010;53:264272.
41. Dudding TC, Parés D, Vaizey CJ, Kamm MA. Comparison of clinical outcome between open and percutaneous lead insertion for permanent sacral nerve neurostimulation for the treatment of fecal incontinence
. Dis Colon Rectum. 2009;52:463468.
42. Tan M, O’Hanlon DM, Cassidy M, O’Connell PR. Advantages of a posterior fourchette incision in anal sphincter repair. Dis Colon Rectum. 2001;44:16241629.
43. Steele SR, Lee P, Mullenix PS, Martin MJ, Sullivan ES. Is there a role for concomitant pelvic floor repair in patients with sphincter defects in the treatment of fecal incontinence
? Int J Colorectal Dis. 2006;21:508514.
44. Osterberg A, Edebol Eeg-Olofsson K, Graf W. Results of surgical treatment for faecal incontinence. Br J Surg. 2000;87:15461552.
45. Briel JW, de Boer LM, Hop WC, Schouten WR. Clinical outcome of anterior overlapping external anal sphincter repair with internal anal sphincter imbrication. Dis Colon Rectum. 1998;41:209214.
46. Wong MT, Meurette G, Stangherlin P, Lehur PA. The magnetic anal sphincter versus the artificial bowel sphincter: a comparison of 2 treatments for fecal incontinence
. Dis Colon Rectum. 2011;54:773779.
47. Wong MT, Meurette G, Wyart V, Lehur PA. Does the magnetic anal sphincter device compare favourably with sacral nerve stimulation in the management of faecal incontinence? Colorectal Dis. 2012;14:e323e329.
48. Abbas MA, Tam MS, Chun LJ. Radiofrequency treatment for fecal incontinence
: is it effective long-term? Dis Colon Rectum. 2012;55:605610.
49. Ruiz D, Pinto RA, Hull TL, Efron JE, Wexner SD. Does the radiofrequency procedure for fecal incontinence
improve quality of life and incontinence at 1-year follow-up? Dis Colon Rectum. 2010;53:10411046.
50. Takahashi-Monroy T, Morales M, Garcia-Osogobio S, et al. SECCA procedure for the treatment of fecal incontinence
: results of five-year follow-up. Dis Colon Rectum. 2008;51:355359.
51. Lefebure B, Tuech JJ, Bridoux V, et al. Temperature-controlled radio frequency energy delivery (Secca procedure) for the treatment of fecal incontinence
: results of a prospective study. Int J Colorectal Dis. 2008;23:993997.
52. Felt-Bersma RJ, Szojda MM, Mulder CJ. Temperature-controlled radiofrequency energy (Secca) to the anal canal for the treatment of faecal incontinence offers moderate improvement. Eur J Gastroenterol Hepatol. 2007;19:575580.
53. Efron JE, Corman ML, Fleshman J, et al. Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence
. Dis Colon Rectum. 2003;46:16061618.
54. Chéreau N, Lefèvre JH, Shields C, et al. Antegrade colonic enema for faecal incontinence in adults: long-term results of 75 patients. Colorectal Dis. 2011;13:e238e242.
55. Worsøe J, Christensen P, Krogh K, Buntzen S, Laurberg S. Long-term results of antegrade colonic enema in adult patients: assessment of functional results. Dis Colon Rectum. 2008;51:15231528.
56. Koivusalo AI, Pakarinen MP, Pauniaho SL, Rintala RJ. Antegrade continence enema in the treatment of congenital fecal incontinence
beyond childhood. Dis Colon Rectum. 2008;51:16051610.
57. Krogh K, Laurberg S. Malone antegrade continence enema for faecal incontinence and constipation in adults. Br J Surg. 1998;85:974977.
58. Oom DM, Gosselink MP, Schouten WR. Anterior sphincteroplasty for fecal incontinence
: a single center experience in the era of sacral neuromodulation. Dis Colon Rectum. 2009;52:16811687.
59. Kaiser AM. Cloaca-like deformity with faecal incontinence after severe obstetric injury: technique and functional outcome of ano-vaginal and perineal reconstruction with X-flaps and sphincteroplasty. Colorectal Dis. 2008;10:827832.
60. Grey BR, Sheldon RR, Telford KJ, Kiff ES. Anterior anal sphincter repair can be of long term benefit: a 12-year case cohort from a single surgeon. BMC Surg. 2007;7:1.
61. Ha HT, Fleshman JW, Smith M, Read TE, Kodner IJ, Birnbaum EH. Manometric squeeze pressure difference parallels functional outcome after overlapping sphincter reconstruction. Dis Colon Rectum. 2001;44:655660.
62. Ho YK, Tan M, Seow-Choen F. Anterior anal sphincter repair for faecal incontinence: anorectal manometric and endoanal ultrasound assessment. Asian J. 1999;22:8992.
63. Sitzler PJ, Thomson JP. Overlap repair of damaged anal sphincter: a single surgeon’s series. Dis Colon Rectum. 1996;39:13561360.
64. Nikiteas N, Korsgen S, Kumar D, Keighley MR. Audit of sphincter repair: factors associated with poor outcome. Dis Colon Rectum. 1996;39:11641170.
65. Gibbs DH, Hooks VH 3rd. Overlapping sphincteroplasty for acquired anal incontinence. South Med J. 1993;86:13761380.
66. Keighley MR. Postanal repair for faecal incontinence. J R Soc Med. 1984;77:285288.
67. Moya P, Arroyo A, Lacueva J, et al. Sacral nerve stimulation in the treatment of severe faecal incontinence: long-term clinical, manometric and quality of life results. Tech Coloproctol. 2014;18:179185.
68. McNevin MS, Moore M, Bax T. Outcomes associated with Interstim therapy for medically refractory fecal incontinence
. Am J Surg. 2014;207:735737.
69. Maeda Y, Lundby L, Buntzen S, Laurberg S. Outcome of sacral nerve stimulation for fecal incontinence
at 5 years. Ann Surg. 2014;259:11261131.
70. Feretis M, Karandikar S, Chapman M. Medium-term results with sacral nerve stimulation for management of faecal incontinence, a single centre experience. Jour Interv Gastroenterol. 2013;3:8288.
71. Damon H, Barth X, Roman S, Mion F. Sacral nerve stimulation for fecal incontinence
improves symptoms, quality of life and patients’ satisfaction: results of a monocentric series of 119 patients. Int J Colorectal Dis. 2013;28:227233.
72. Faucheron JL, Chodez M, Boillot B. Neuromodulation for fecal and urinary incontinence: functional results in 57 consecutive patients from a single institution. Dis Colon Rectum. 2012;55:12781283.
73. Pascual I, Gómez Cde C, Ortega R, et al. Sacral nerve stimulation for fecal incontinence
. Rev Esp Enferm Dig. 2011;103:355359.
74. Mellgren A, Wexner SD, Coller JA, et al.; SNS Study Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence
. Dis Colon Rectum. 2011;54:10651075.
75. Maeda Y, Lundby L, Buntzen S, Laurberg S. Suboptimal outcome following sacral nerve stimulation for faecal incontinence. Br J Surg. 2011;98:140147.
76. Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence
: results of a 120-patient prospective multicenter study. Ann Surg. 2010;251:441449.
77. Michelsen HB, Thompson-Fawcett M, Lundby L, Krogh K, Laurberg S, Buntzen S. Six years of experience with sacral nerve stimulation for fecal incontinence
. Dis Colon Rectum. 2010;53:414421.
78. Faucheron JL, Voirin D, Badic B. Sacral nerve stimulation for fecal incontinence
: causes of surgical revision from a series of 87 consecutive patients operated on in a single institution. Dis Colon Rectum. 2010;53:15011507.
79. El-Gazzaz G, Zutshi M, Salcedo L, Hammel J, Rackley R, Hull T. Sacral neuromodulation for the treatment of fecal incontinence
and urinary incontinence in female patients: long-term follow-up. Int J Colorectal Dis. 2009;24:13771381.
80. Hetzer FH, Hahnloser D, Clavien PA, Demartines N. Quality of life and morbidity after permanent sacral nerve stimulation for fecal incontinence
. Arch Surg. 2007;142:813.
81. Rasmussen OO, Buntzen S, Sørensen M, Laurberg S, Christiansen J. Sacral nerve stimulation in fecal incontinence
. Dis Colon Rectum. 2004;47:11581162.
82. Jarrett ME, Varma JS, Duthie GS, Nicholls RJ, Kamm MA. Sacral nerve stimulation for faecal incontinence in the UK. Br J Surg. 2004;91:755761.
83. Kenefick NJ, Vaizey CJ, Cohen RC, Nicholls RJ, Kamm MA. Medium-term results of permanent sacral nerve stimulation for faecal incontinence. Br J Surg. 2002;89:896901.
84. Boenicke L, Kim M, Reibetanz J, Germer CT, Isbert C. Stapled transanal rectal resection and sacral nerve stimulation: impact on faecal incontinence and quality of life. Colorectal Dis. 2012;14:480489.
85. Hull T, Giese C, Wexner SD, et al.; SNS Study Group. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence
. Dis Colon Rectum. 2013;56:234245.
86. Hultman CS, Zenn MR, Agarwal T, Baker CC. Restoration of fecal continence after functional gluteoplasty: long-term results, technical refinements, and donor-site morbidity. Ann Plast Surg. 2006;56:6570.
87. Darnis B, Faucheron JL, Damon H, Barth X. Technical and functional results of the artificial bowel sphincter for treatment of severe fecal incontinence
: is there any benefit for the patient? Dis Colon Rectum. 2013;56:505510.
88. Wong MT, Meurette G, Wyart V, Glemain P, Lehur PA. The artificial bowel sphincter: a single institution experience over a decade. Ann Surg. 2011;254:951956.
89. Michot F, Lefebure B, Bridoux V, et al. Artificial anal sphincter for severe fecal incontinence
implanted by a transvaginal approach: experience with 32 patients treated at one institution. Dis Colon Rectum. 2010;53:11551160.
90. Ruiz Carmona MD, Alós Company R, Roig Vila JV, Solana Bueno A, Pla Martí V. Long-term results of artificial bowel sphincter for the treatment of severe faecal incontinence: are they what we hoped for? Colorectal Dis. 2009;11:831837.
91. Melenhorst J, Koch SM, van Gemert WG, Baeten CG. The artificial bowel sphincter for faecal incontinence: a single centre study. Int J Colorectal Dis. 2008;23:107111.
92. Casal E, San Ildefonso A, Carracedo R, Facal C, Sánchez JA. Artificial bowel sphincter in severe anal incontinence. Colorectal Dis. 2004;6:180184.
93. Parker SC, Spencer MP, Madoff RD, Jensen LL, Wong WD, Rothenberger DA. Artificial bowel sphincter: long-term experience at a single institution. Dis Colon Rectum. 2003;46:722729.
94. Wong WD, Congliosi SM, Spencer MP, et al. The safety and efficacy of the artificial bowel sphincter for fecal incontinence
: results from a multicenter cohort study. Dis Colon Rectum. 2002;45:11391153.
95. Ortiz H, Armendariz P, DeMiguel M, Ruiz MD, Alós R, Roig JV. Complications and functional outcome following artificial anal sphincter implantation. Br J Surg. 2002;89:877881.
96. Devesa JM, Rey A, Hervas PL, et al. Artificial anal sphincter: complications and functional results of a large personal series. Dis Colon Rectum. 2002;45:11541163.
97. Altomare DF, Dodi G, La Torre F, Romano G, Melega E, Rinaldi M. Multicentre retrospective analysis of the outcome of artificial anal sphincter implantation for severe faecal incontinence. Br J Surg. 2001;88:14811486.
98. O’Brien PE, Skinner S. Restoring control: the acticon neosphincter artificial bowel sphincter in the treatment of anal incontinence. Dis Colon Rectum. 2000;43:12131216.
99. Lehur PA, Roig JV, Duinslaeger M. Artificial anal sphincter: prospective clinical and manometric evaluation. Dis Colon Rectum. 2000;43:11001106.
100. Christiansen J, Rasmussen OO, Lindorff-Larsen K. Long-term results of artificial anal sphincter implantation for severe anal incontinence. Ann Surg. 1999;230:4548.
101. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309:814822.
102. Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:19871991.
103. Moher D, Hopewell S, Schulz KF, et al.; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63:e1e37.
104. Mowatt G, Glazener CM, Jarrett M. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database of Systematic Reviews. 2007;(3):CD004464.
105. Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. 2014;109:11411058.
106. Paquette IM, Varma MG, Kaiser AM, Steele SR, Rafferty JF. The American Society of Colon and Rectal Surgeons’ Clinical Practice Guideline for the Treatment of Fecal Incontinence
. Dis Colon Rectum. 2015;58:623636.
107. Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems.Gut. 1999 7780.
108. Lunniss PJ, Kamm MA, Phillips RK. Factors affecting continence after surgery
for anal fistula.Br J Surg. 1994 Sep;81(9):13825.
109. Jorge JM, Wexner SD. Etiology and management of fecal incontinence
. Dis Colon Rectum. 1993;36:7797.
110. Rockwood TH, Church JM, Fleshman JW, et al. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence
: the fecal incontinence
severity index. Dis Colon Rectum. 1999;42:15251532.
111. Moher D, Pham B, Klassen TP, et al. What contributions do languages other than English make on the results of meta-analyses? J Clin Epidemiol. 2000;53:964972.
112. Morrison A, Polisena J, Husereau D, et al. The effect of English-language restriction on systematic review
-based meta-analyses: a systematic review
of empirical studies. Int J Technol Assess Health Care. 2012;28:138144.
113. Melenhorst J, Koch SM, Uludag O, van Gemert WG, Baeten CG. Is a morphologically intact anal sphincter necessary for success with sacral nerve modulation in patients with faecal incontinence? Colorectal Dis. 2008;10:257262.
114. Chan MK, Tjandra JJ. Sacral nerve stimulation for fecal incontinence
: external anal sphincter defect vs. intact anal sphincter. Dis Colon Rectum. 2008;51:10151025.