Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study.

BACKGROUND: Non-randomised studies assessing intrarectal botulinum toxin type A (BoNTA) injections for faecal incontinence are promising. We aimed to evaluate the efficacy of BoNTA for the treatment of faecal incontinence in a randomised study. METHODS: In this randomised, double-blind, placebo-controlled study, we included adult patients who had at least one urgency or faecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment from eight French specialist hospital units with the skills to manage patients with faecal incontinence. Patients were randomly assigned (1:1) by a central web form to receive intrarectal submucosal injections of either 200 units of BoNTA (Botox; Allergan, Irvine, CA, USA; BoNTA group) or an equivalent volume of saline (placebo group), stratified by Cleveland Clinic Severity scores (CCS score; ≥12 or <12). Patients, investigators, study site staff, and sponsor personnel were masked to treatment allocation up to the 6-month visit. The primary endpoint was the number of episodes of faecal incontinence and urgency per day assessed using 21-day patient bowel diaries 3 months after the treatment. The primary analysis was performed using a modified intention-to-treat (mITT) approach (ie, in all the randomised patients who had received a treatment) with adjustment for baseline faecal incontinence and urgency episodes. After the final data collection at 6 months after injections, patients were unmasked and offered the BoNTA treatment if they were in the placebo group (rescue therapy) without masking, with an additional 6 months of safety follow-up. This trial is registered with ClinicalTrials.gov, number NCT02414425. FINDINGS: Between Nov 25, 2015, and Nov 25, 2020, we randomly assigned 200 patients to receive either BoNTA (n=100) or placebo (n=100) injections. Due to withdrawals before the injections, 96 patients were included in the BoNTA group and 95 patients were included in the placebo group (mITT analysis). The mean number of faecal incontinence and urgency episodes per day in the BoNTA group decreased from 1·9 (SD 2·2) at baseline to 0·8 (1·8) at 3 months after the injections, and from 1·4 (1·1) to 1·0 (1·0) in the placebo group, with a baseline-adjusted mean group difference at 3 months estimated at -0·51 (95% CI -0·80 to -0·21, p=0·0008). No serious treatment-related adverse events were reported in the trial. The most frequently reported non-serious adverse event (treatment related or not) following the BoNTA or placebo injections was constipation (reported in 68 [40%] of 169 patients who received the BoNTA injections and 38 [40%] of 95 patients who received placebo injections). INTERPRETATION: BoNTA injections are an efficacious treatment for urge faecal incontinence. Further research will define the optimum selection criteria, dose, site of injection, re-injection frequency, and long-term results. FUNDING: General Direction of Healthcare (French Ministry of Health).

Interferential therapy for chronic constipation in adults: The CON-COUR randomizedcontrolled trial.

BACKGROUND: Chronic constipation (CC) is a frequent condition, and the first-line treatment includes dietary rules, the use of laxatives, and biofeedback for evacuation disorders. However, almost half of the patients are dissatisfied with their current treatment. We report the first double-blind randomized multicenter trial assessing the effectiveness of transabdominal electrical stimulation by interferential therapy (IFT) in the treatment of CC in adults. METHODS: A prospective, multicenter, randomized, double-blind, sham-controlled, parallel-group, phase 3 trial was conducted at 7 centers in France. The primary endpoint was 8-week efficacy as defined by the number of complete spontaneous bowel movements during the last 4 weeks of the 8-week stimulation period. Secondary endpoints included the evaluation of the effects of IFT on symptoms (Patient Assessment of Constipation Symptoms questionnair (PAC-SYM)), quality of life (QOL) (Patient Assessment of Constipation Quality of Life), Colonic transit time (CTT), anorectal manometry, and patient satisfaction. RESULTS: The proportion of 8-week responders was not significantly different between the two groups (73.2% in the IFT group vs. 67.1% in the sham group). After 8 weeks of stimulation, the mean overall PAC-SYM score and the mean reduction in the overall PAC-SYM score were significantly greater in the IFT group than in the sham group. No differences were observed concerning CTT, anorectal manometry, or patient satisfaction. CONCLUSIONS: Although the primary endpoint was not reached, IFT can significantly alleviate the symptoms and improve the QOL of CC patients. It can be assumed that new treatments require different modes of evaluation and that the assessment of patient-reported outcomes may become a priority among therapeutic targets of CC. Trial registration number NCT02381665.

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

Risk of Fecal Incontinence Following Receptive Anal Intercourse: Survey of 21,762 Men Who Have Sex With Men.

BACKGROUND: The prevalence of receptive anal intercourse (RAI) is increasing. A few studies, with heterogeneous designs, have investigated the associated risk of fecal incontinence (FI). AIM: The primary objective of this study was to determine FI prevalence in a population of men who have sex with men (MSM) engaging in RAI. The secondary objective was to identify risk factors for severe FI. METHODS OUTCOMES: An online survey of 24,308 MSM was performed in 2019. Demographic and socioeconomic data were collected, together with information about RAI sexual practices, and FI defined by: "During the last month, have you experienced any involuntary leakage of stools?" RESULTS CLINICAL IMPLICATIONS: In total, 1,734 (8%) of the 21,762 participants reported FI. Mean age was 35.3 years. The prevalence of FI was correlated with RAI frequency: 12.7% (if RAI ≥ 1 /wk) versus 5.7% (if no RAI). In multivariate analysis, the factors associated with FI were age (OR: 1.01), low socioeconomic status (OR 1.32 to 1.40), HIV-seropositivity (OR: 1.78), high RAI frequency (OR: 1.64), chemsex (OR: 1.67) and fist-fucking (OR: 1.61). STRENGTHS AND LIMITATIONS: Main strengths of our study are population size and assessment of detailed modalities of sexual practices. Main limitations are the use of a convenience non-random sample and the assessment of FI only during the past month. CONCLUSION: This study of a large MSM population, highlights risk factors for FI among RAI practices: RAI ≥ 1 /wk, chemsex, fist-fucking, low socioeconomic status. Garros A, Bourrely M, Sagaon-Teyssier L, et al. Risk of Fecal Incontinence Following Receptive Anal Intercourse: Survey of 21,762 Men Who Have Sex With Men. J Sex Med 2021;18:1880-1890.

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study.

AIM: The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStimTM system for the treatment of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable. METHOD: This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow-up visits within 1 and 15 months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events. RESULTS: A total of 221 subjects with a mean age of 62.1 years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow-up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1-3, 4-8 and 9-15 months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p < 0.0001). Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device-related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports. CONCLUSION: This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real-life.

Efficacy and safety of sacral nerve modulation for faecal incontinence after pelvic radiotherapy.

OBJECTIVE: To assess the efficacy and safety of sacral nerve modulation (SNM) in patients with faecal incontinence (FI) after pelvic radiotherapy in comparison with results of SNM for FI related to other conditions. METHODS: Prospectively collected data from patients who underwent SNM therapy between January 2010 and December 2015 at 7 tertiary colorectal units were reviewed retrospectively. Patients with FI following pelvic radiotherapy were identified and matched (1:2) for age and sex with 38 patients implanted over the same period for FI without previous radiotherapy. The treatment was considered favourable if the patient reported any therapeutic benefit from SNM, had no further complaints or interventions and did not consider stopping the treatment. Long-term results, surgical revision and definitive explantation rates were compared. RESULTS: Among 352 patients who received a permanent SNM implant, 19 (5.4%) had FI following pelvic radiotherapy. After a mean follow-up of 3.5 ± 1.9 years, the cumulative successful treatment rates were similar between the groups (p = 0.60). For patients with FI following pelvic radiotherapy, the cumulative success rates were 99.4% [85.4-99.8], 96.7% [78.1-99.6], 91.7% [70.4-98.1] and 74.6% [48.4-94.8] at 1, 2, 3 and 5 years respectively. The revision and definitive explantation rates for infection did not differ significantly. CONCLUSION: The long-term success rate of SNM for FI after pelvic radiotherapy is similar to that of SNM for FI related to other more frequent conditions. Our study suggests that FI after pelvic radiotherapy could be improved with SNM without an increased risk of complication.

Is Sacral Nerve Modulation a Good Option for Fecal Incontinence in Men?

OBJECTIVE: The objective was to assess the efficacy and the safety of sacral nerve modulation (SNM) in men with fecal incontinence (FI) compared with those of SNM in women. METHOD: Prospectively collected data from patients from seven tertiary colorectal units who underwent an implant procedure between January 2010 and December 2015 were reviewed retrospectively. Outcomes and surgical revision and definitive explantation rates were compared between men and women. RESULTS: A total of 469 patients (60 men [12.8%]; mean age = 61.4 ± 12.0 years) were included in the study, 352 (78.1%) (31 men [8.8%]) of whom received a permanent implant. The ratio of implanted/tested men was significantly lower than the ratio of implanted/tested women (p = 0.0004). After a mean follow-up of 3.4 ± 1.9 years, the cumulative successful treatment rates tended to be less favorable in men than in women (p = 0.0514): 88.6% (75.6-95.1), 75.9% (60.9-86.4), 63.9% (48.0-77.3), and 43.9% (26.7-62.7) at one, two, three, and five years, respectively, in men; 92.0% (89.1-94.2), 84.2% (80.3-87.4), 76.8% (72.3-80.7), and 63.6% (57.5-69.3) at one, two, three, and five years, respectively, in women. The revision rate for infection and the definitive explantation rate for infection were higher in men than in women (p = 0.0001 and p = 0.0024, respectively). CONCLUSION: Both short- and long-term success rates of SNM for FI were lower in men than in women. The revision and definitive explantation for long-term infection rates were significantly higher in men.

Anal sphincter function as assessed by 3D high definition anorectal manometry.

PURPOSE: High resolution anorectal manometry has been developed over the past years, as well as 3D high definition manometry (HDARM). However, the clinical impact of the results obtained with these new technologies remains to be determined. We thus analyzed various HDARM parameters of anal sphincter function and tested their capacity to discriminate between patients with constipation and those with fecal incontinence. METHODS: One hundred and fourteen consecutive patients underwent the same HDARM protocol (Medtronic), including 2 short duration voluntary anal contractions (5seconds) and 1 sustained (as long as possible) contraction. Various parameters evaluating the anal sphincter function were measured, based on automatic software analysis and Smartmouse™ item of the software; resting anal pressures, anal pressures and incremental pressures during voluntary squeeze and cough anal reflex. The ability of these parameters to discriminate between patients with fecal incontinence and chronic constipation was assessed using areas under the curves of ROC curves. RESULTS: All parameters were highly correlated. The most discriminant variable was found to be the mean anal pressure during sustained squeeze. The 3D lambda aspect of the anal sphincter during voluntary contraction was as frequently absent in both groups of patients (13% in patients with chronic constipation, versus 23% in those with fecal incontinence, P=0.18). There was a significant correlation between the fecal incontinence Wexner score and the voluntary anal contraction variables. CONCLUSIONS: Several parameters to assess the quality of voluntary anal contraction have been proposed. We observed with HDARM that the most discriminant parameter was the mean anal pressure during sustained squeeze. This may help to standardize and simplify HDARM protocols.

Clinical practice guidelines from the French National Society of Coloproctology in treating chronic constipation.

Chronic constipation is a common symptom that regularly affects the quality of life of adult patients. Its treatment is mainly based on dietary rules, laxative drugs, perineal rehabilitation and surgical treatment. The French National Society of Coloproctology offers clinical practice recommendations on the basis of the data in the current literature, including those on recently developed treatments. Most are noninvasive, and the main concepts include the following: stimulant laxatives are now considered safe drugs and can be more easily prescribed as a second-line treatment; biofeedback therapy remains the gold standard for the treatment of anorectal dyssynergia that is resistant to medical treatment; transanal irrigation is the second-line treatment of choice in patients with neurological diseases, but it may also be proposed for patients without neurological diseases; and although interferential therapy may be a new promising treatment, it needs further evaluation.

Long-term outcome after overlapping anterior anal sphincter repair for fecal incontinence.

PURPOSE: The aim was to assess long-term results and quality of life following anterior anal sphincter repair for anal incontinence. PATIENTS AND METHODS: Twenty-three female patients underwent anterior anal sphincteroplasty over a 10-year period between January 1999 and January 2009 in a gynecological surgery department. Patients were asked to complete pre- and postoperative questionnaires comprising the Jorge and Wexner incontinence score. The secondary objective was to assess pre- and post-sphincteroplasty symptom severity and sexual quality of life. Mean follow-up was 87 months (median, 91.5 months). Kaplan-Meier time-to-event analysis was applied. RESULTS: Mean age was 52 years (±15.2), and mean postoperative Jorge and Wexner score, 7.5/20 (±4.1). Seventeen patients (85 %) declared themselves satisfied by the repair; 12 (60 %) showed good fecal continence. Fecal incontinence had a negative impact on quality of life for 15 % and on sexuality for 50 % of patients. Kaplan-Meier analysis showed 85 % conservation of anal continence correction at 1 year, 74 % at 48 months, 67 % at 60 months, and 48 % at 84 months. CONCLUSIONS: Overlapping anterior anal sphincter repair provided lasting improvement in fecal incontinence, with satisfactory long-term functional results. At 84 months' follow-up, 48 % of patients maintained good fecal continence, with a satisfaction rate of 85 %. Anal sphincteroplasty may be a first-line attitude in young female fecal incontinence patients with a recent sphincter defect following initially undiagnosed obstetric trauma and also restores perineal comfort.

Perineal retraining improves conservative treatment for faecal incontinence: a multicentre randomized study.

BACKGROUND: Anal incontinence is a frequent complaint that profoundly affects quality of life. Our aim was to determine whether perineal retraining gives additional benefits to standard medical treatment. METHODS: Patients with anal incontinence and a Wexner score >4 were randomly assigned to standard conservative treatment (control) or perineal retraining, including biofeedback, in addition to standard treatments (biofeedback). Diaries, self-administered questionnaires and satisfaction scores quantified the benefits. Self-evaluated improvement was the primary outcome measure. A score ≥3 (in an improvement scale from -5 to +5) defined success. RESULTS: Overall, 157 patients were included; 80 in the control group (75% females, mean age 60.1 ± 13.2 years) and 77 in the biofeedback group (79% females, mean age 61.9 ± 10.2 years). After a 4-month follow-up, the success rate was significantly higher in the biofeedback group (57% versus 37%; p<0.021). In the biofeedback group, daily stool frequency, leakage, and faecal urgency significantly decreased, and daily non-urgent perception of stool increased. Conversely, symptomatic scores and quality of life scales did not significantly differ between groups. In a multivariate model, the adjusted odds ratio showed that perineal retraining was significantly associated with a higher chance of self-rated improvement (adjusted Odd Ratio [95%CI]: 2.34 [1.14-4.80]; p=0.021). CONCLUSIONS: Perineal retraining offers a moderate but significant benefit for patients suffering from anal incontinence.

Technical and functional results of the artificial bowel sphincter for treatment of severe fecal incontinence: is there any benefit for the patient?

BACKGROUND: Fecal incontinence is a socially devastating problem that can be cured by the artificial bowel sphincter in selected cases. OBJECTIVE: This study evaluates short- and long-term morbidity and functional results of the artificial bowel sphincter. DESIGN: This study is a retrospective evaluation of consecutive patients. SETTINGS: This study was conducted at 2 academic colorectal units. PATIENTS: Between May 2003 and July 2010, all consecutive patients who underwent artificial bowel sphincter implantation for severe fecal incontinence were included in the study. INTERVENTION: The artificial bowel sphincter was implanted through 2 incisions made in the perineum and suprapubic area. MAIN OUTCOME MEASURES: Patients were reviewed at months 1, 6, and 12, and then annually. Mortality, morbidity (early infection within the first 30 days after implant, and late thereafter), and reoperations including explantations were analyzed. Anal continence was evaluated by means of the Cleveland Clinic Florida score. Mean follow-up was 38 months (range, 12-98). RESULTS: Between May 2003 and July 2010, 21 consecutive patients with a mean age of 51 years (range, 23-71) underwent surgery. There was no mortality. All patients presented with at least 1 complication. Infection or cutaneous ulceration occurred in 76% of patients, perineal pain in 29%, and rectal evacuation disorders in 38%. The artificial bowel sphincter was definitely explanted from 17 patients (81%). The artificial sphincter was able to be activated in 17 patients (81%), and continence was satisfactory at 1 year in those who still had their sphincter in place (n = 12). CONCLUSION: There is a very high rate of morbidity and explantation after implantation of an artificial bowel sphincter for fecal incontinence. Four of 21 patients who still had an artificial sphincter in place had satisfactory continence at a mean follow-up of 38 months.

Sacral nerve stimulation for fecal incontinence improves symptoms, quality of life and patients' satisfaction: results of a monocentric series of 119 patients.

PURPOSE: Sacral nerve stimulation (SNS) is validated as an efficient treatment for fecal incontinence (FI). However, long-term results are scarce in the literature. The goal of this study was to assess the impact of SNS on FI symptoms and quality of life, based on a retrospective analysis of prospectively collected data. METHODS: From 2001 to 2009, 119 patients (six men, mean age 61 years) underwent SNS testing for FI after an extensive diagnostic workup. Permanent implantation was realized when FI symptoms improved during testing, and follow-up visits were performed every 12 months thereafter. This follow-up evaluated morbidity and efficacy, based on clinical data and self-administered questionnaires including Jorge and Wexner FI score, urinary incontinence score (urinary distress inventory-6, UDI-6), gastrointestinal quality of life index (GIQLI), and auto-evaluation scale. RESULTS: A permanent stimulator was implanted after a positive test in 102 patients (91 %). Ten patients were explanted during follow-up (pain in one case and absence of efficacy in nine), and 29 had the stimulator and/or the electrode changed. The mean follow-up was 48 months (range 12-84): there was a significant improvement of FI score (9 ± 1 vs 14 ± 3, p < 0.0001), UDI-6 score (8 ± 4 vs 11 ± 5, p < 0.05), and GIQLI index (p < 0.002). The improvement was present at 12 months follow-up and remained stable. Eighty percent of patients were satisfied with the treatment at the last point of follow-up. None of the pretreatment variables were predictive of SNS efficacy. CONCLUSIONS: SNS improved FI and quality of life, and this efficacy remained over time. Although a complete disappearance of FI was rare, most patients were satisfied.

Can sacral neuromodulation improve minor incontinence symptoms in doubly incontinent patients successfully treated for major incontinence symptoms?

OBJECTIVE: To describe the effect of sacral nerve modulation (SNM) on less severe types of incontinence in patients who were successfully implanted for either urinary or fecal incontinence, and who presented with double incontinence. When conservative treatments fail, SNM is a first-line treatment for patients with urge urinary or fecal incontinence. METHODS: All patients who received SNM between 2005 and 2010 at 5 hospitals and who still had the implant were included in our survey. All received a urinary and fecal change and quality of life questionnaire by mail to complete. RESULTS: Of the 51 questionnaires sent out, 37 were returned, for a 72.5% response rate. The population was composed of 97.3% women, with a mean age of 56.8 years (SD 14). The main indication for SNM was urge urinary incontinence in 15 patients (40.5%) and fecal incontinence in 22 patients (59.5%). Eighteen patients (48.7%) had improvements in both urinary and fecal incontinence symptoms. The percentage increased to 53.3% (16/30) in the group of patients with urge urinary incontinence associated with fecal incontinence. Patients who reported an improvement in double incontinence symptoms complained more often of urge urinary incontinence than other patients (P=.04). CONCLUSIONS: Of the doubly incontinent patients who were successfully implanted for a predominant type of incontinence (ie, urinary or fecal incontinence), 48.7% had an improvement in the other type of incontinence. Patients with urge urinary incontinence associated with fecal incontinence were more likely to report an improvement in double incontinence than the other patients.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Transcutaneous electrical posterior tibial nerve stimulation for faecal incontinence: effects on symptoms and quality of life.

PURPOSE: Faecal incontinence is a disabling symptom which may be particularly difficult to treat. Recent studies showed that transcutaneous electrical posterior tibial nerve stimulation may improve faecal continence. In this study, we aimed to evaluate the effectiveness of this technique and tried to individualize predictive factors of success. METHODS: Twenty-four patients suffering from faecal incontinence were treated 20 min per day by applying transcutaneous electrical posterior tibial nerve stimulation for 3 months. A clinical evaluation was performed at the end of treatment, with Wexner's score and analogical scales for symptoms. After 3 months, if the treatment was successful, patients were proposed to continue on the treatment. Predictive factors such as age, symptom duration, proctologic history, obstetrical history, ano-rectal manometric data and quality-of-life score were also analysed. RESULTS: At 3 months, 13 patients (54%) reported a significant symptomatic improvement with a significant modification in the Wexner's score (14 vs 12, p < 0.025). At a median follow-up of 15 months, there were still 11 patients whose condition was improved. CONCLUSION: This study shows encouraging mid-term results, and even if further randomized studies are necessary, transcutaneous electrical posterior tibial nerve stimulation may be a new and easy-to-use therapeutic option to treat faecal incontinence.

Transcutaneous posterior tibial nerve stimulation for fecal incontinence in inflammatory bowel disease patients: a therapeutic option?

BACKGROUND: Fecal incontinence associated with inflammatory bowel disease (IBD) may be particularly difficult to treat. Two recent studies showed that transcutaneous posterior tibial nerve stimulation may improve fecal continence. In this pilot study, we tested the usefulness of this noninvasive technique to treat fecal incontinence in IBD. METHODS: Twelve patients with IBD (7 Crohn's disease, 2 undetermined colitis, 3 ulcerative colitis) were treated by applying transcutaneous posterior tibial nerve electrical stimulation daily for 3 months. A clinical evaluation was performed at the end of treatment, with Wexner's score and Harvey-Bradshaw index and analog scales to assess symptoms and quality of life. RESULTS: At 3 months, 5 patients (41.6%) reported a significant symptomatic and quality of life improvement, although only 1 reported a significant modification in the Wexner score. CONCLUSION: These preliminary results are encouraging, although further studies are necessary. Posterior tibial nerve electrical stimulation may represent a new therapeutic option to treat the difficult problem of fecal incontinence in patients with IBD.

Clinical characteristics and quality of life in a cohort of 621 patients with faecal incontinence.

AIM: The aim of this study was to study a cohort of patients with faecal incontinence (FI) to gain a better insight into the clinical and epidemiological characteristics of this pathology and its repercussions on quality of life (QL). MATERIALS AND METHODS: Consecutive patients with FI seen at tertiary centres filled in a self-questionnaire. The severity of FI, constipation and urinary incontinence (UI) was evaluated, respectively, by the Jorge and Wexner score, the Knowles-Eccersley-Scott Symptom score and the Urological Distress Inventory score. ROME II criteria were used to assess the existence of an associated irritable bowel syndrome. The repercussion on QL was evaluated by the Gastrointestinal Quality of Life index score and the Ditrovie score. The psychological status was assessed by the Hospital Anxiety and Depression scale. RESULTS: Six hundred twenty-one patients (114 men), mean age 58 +/- 15 years (range: 20-92), with FI, filled in the questionnaire. The mean Jorge and Wexner score was 11 +/- 4. Twenty-seven presented with an irritable bowel syndrome. Thirty-eight percent had an associated constipation. A UI was associated in 48% women and 25% men. QL was significantly altered, and anxiety and depression were frequent. CONCLUSIONS: FI symptoms are frequently severe, QL very altered and anxiety and depression common. FI is frequently associated with other digestive and perineal symptoms, which argue in favour of a multi-disciplinary management of FI.

Prevalence of anal incontinence in adults and impact on quality-of-life.

OBJECTIVE: To investigate the prevalence of anal incontinence in the general population and in patients consulting gastroenterologist and gynecologist practices in the Rhône Alpes area. METHODS: For the first study a questionnaire was sent to a sample of 2800 people selected randomly from the electoral roll. Another study of patients selected randomly among patients attending gynecology and gastroenterology consultations was performed. A Jorge & Wexner score above or equal to 5 was used to define anal incontinence. RESULTS: For the first study, a total of 706 questionnaires was analyzed: the prevalence of anal incontinence was 5.1% [95% CI: 3.6-7.0] and the scores of each dimension of the SF-12 Health Survey were significantly lower among incontinent people than among continent people. The prevalence was significantly higher for women (7.5% [5.0-10.7]) than for men (2.4% [1.1-4.7]). Eighty-four physicians returned 835 valid questionnaires. The prevalence was 13.1% [10.1-16.6] among patients attending gastroenterology consultations and 5.0% [3.1-7.6] among those attending gynecology consultations. For 84.8% of the incontinent patients, the physician was unaware of the patient's disorder. CONCLUSION: The prevalence figures we obtained coincide with data in the literature. This disorder is common and affects the patient's quality-of-life, but remains underestimated and under-diagnosed.