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To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. The aim of this study was to investigate the optimal dose frequency, clinical effects, and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. Patients with FI were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1, 5, or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensorimotor function, and quality of life were compared. Primary outcome measure was the change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. Thirty-three patients with FI participated. FI episodes decreased significantly (∆ ±95% confidence interval, 4.2 ± 2.8 (1 Hz); 2 ± 1.7 (5 Hz); 3.4 ± 2.5 (15 Hz); P < 0.02) in all 3 groups when compared with baseline. The 1 Hz group showed a significantly higher (P = 0.04) responder rate (91 ± 9.1%) when compared with the 5 Hz group (36 ± 18.2%) or 15 Hz (55 ± 18.2%); no difference was found between the 5 and 15 Hz groups (P = 0.667). Anal neuropathy, squeeze pressure, and rectal capacity improved significantly only in the 1 Hz (P < 0.05) group compared with baseline, but not in other groups. Quality of life domains improved significantly (P < 0.05) with 1 and 5 Hz groups. No device-related serious adverse events were noted. TNT significantly improves FI symptoms in the short term, and the 1 Hz frequency was overall better than 5 and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and noninvasive treatment for FI (see Visual Abstract, Supplementary Digital Content 3, http://links.lww.com/AJG/B598).

Introduction and hypothesisOur primary objective was to prospectively evaluate anorectal symptoms, anal manometry and endoanal ultrasound (EAUS) in women who followed the recommended mode of subsequent delivery following index obstetric anal sphincter injuries (OASIs) using our unit’s standardised protocol. Our secondary objectives were to evaluate the role of internal anal sphincter defects and also to compare outcomes in a subgroup of symptomatic women with normal anorectal physiology.MethodsThis is a prospective follow-up study of pregnant women with previous OASIs who were counselled regarding subsequent mode of delivery between January 2003 and December 2014. Assessment involved the St Mark’s Incontinence Score (SMIS), anal manometry and EAUS at both antepartum and 3-month postpartum visits. Data were analysed using Wilcoxon and Mann–Whitney U tests.ResultsThree hundred and fifty women attended the perineal clinic over the study period, of whom 122 met the inclusion criteria (99 vaginal delivery [VD], 23 caesarean section). No significant worsening of anorectal symptoms was observed following subsequent delivery in the VD group (p = 0.896), although a reduced squeeze pressure was observed at 3 months postpartum (p < 0.001). There were no new defects on EAUS in either group.ConclusionsThis study showed no significant worsening of bowel symptoms and sphincter integrity apart from lower squeeze pressures at 3 months postpartum in the VD group when our standardised protocol was used to recommend subsequent mode of delivery. In the absence of a randomised study, use of this protocol can aid clinicians in their decision-making.

Purpose To describe experiences of a 3-month pelvic floor muscle training (PFMT) period, with or without support from a physiotherapist, among females with urinary and/or fecal incontinence after pelvic radiotherapy. Method This qualitative interview study included eleven women (aged 47–83 years) with urinary and/or fecal incontinence after radiotherapy treatment for pelvic cancer (radiotherapy completed 3–60 months ago). The eleven informants were part of a larger randomized controlled intervention study where they practiced PFMT, with or without support from a physiotherapist, for 3 months. The support from a physiotherapist included individual support with biofeedback as well as group training. The women were interviewed individually soon after the completion of the pelvic floor muscle training period, and data were analyzed with qualitative content analysis. Result A structured training program, individual support from a physiotherapist, and strategies to establish a daily workout routine were described as valuable when practicing pelvic floor muscle training. Participating in the study gave a sense of meaningfulness and motivation to practice, partly due to the knowledge of a follow-up after the study period. Group and home training were described as both a facilitator and a barrier to PFMT. The women experienced that PFMT had influenced pelvic floor function in terms of increased pelvic floor strength, reduced urinary and fecal incontinence, and an increased ability to hold urine and feces during urgency. PFMT had a relieving effect on pelvic floor pain, although it also contributed to some increase in pain. The perceived improvement in pelvic muscle function led to decreased anxiety, increased safety, feelings of greater freedom in everyday life, a changed attitude toward physical activity, and improved sexual health. All women expressed an intention to continue practicing PFMT and a desire for information and opportunities for PFMT, under the guidance of a physiotherapist, to be implemented in conventional pelvic cancer rehabilitation and made available to all women after pelvic cancer treatment. Conclusion The women who live with the experience of pelvic cancer experienced PFMT as a meaningful intervention for managing urinary and/or fecal incontinence after pelvic radiotherapy. They considered that information and support from a physiotherapist are essential in pelvic cancer rehabilitation, such as PFMT, and should be offered to all women after pelvic cancer treatment.

ObjectiveLack of standardised outcomes hampers effective analysis and comparison of data when comparing treatments in fistulising perianal Crohn’s disease (pCD). Development of a standardised set of outcomes would resolve these issues. This study provides the definitive core outcome set (COS) for fistulising pCD.DesignCandidate outcomes were generated through a systematic review and patient interviews. Consensus was established via a three-round Delphi process using a 9-point Likert scale based on how important they felt it was in determining treatment success culminating in a final consensus meeting. Stakeholders were recruited nationally and grouped into three panels (surgeons and radiologists, gastroenterologists and IBD specialist nurses, and patients). Participants received feedback from their panel (in the second round) and all participants (in the third round) to allow refinement of their scores.ResultsA total of 295 outcomes were identified from systematic reviews and interviews that were categorised into 92 domains. 187 stakeholders (response rate 78.5%) prioritised 49 outcomes through a three-round Delphi study. The final consensus meeting of 41 experts and patients generated agreement on an eight domain COS. The COS comprised three patient-reported outcome domains (quality of life, incontinence and a combined score of patient priorities) and five clinician-reported outcome domains (perianal disease activity, development of new perianal abscess/sepsis, new/recurrent fistula, unplanned surgery and faecal diversion).ConclusionA fistulising pCD COS has been produced by all key stakeholders. Application of the COS will reduce heterogeneity in outcome reporting, thereby facilitating more meaningful comparisons between treatments, data synthesis and ultimately benefit patient care.

High horseshoe-shaped anal fistula (HHAF) is a complicated and challenging condition that presents considerable obstacles in treatment. We are presently investigating a novel surgical technique involving a combination of multi-incision and tube-dragging therapy, and laser closure (MITD-LaC) for the management of HHAF. Due to the current scarcity of rigorous evidence evaluating this approach, it is essential to perform a well-designed randomized controlled trial to compare the effectiveness of this new method with incision and thread-drawing therapy. This trial is a prospective, randomized, controlled and interventional study. After preliminary screening of qualified outpatients, a total of 64 adult patients will be enrolled in the trial and randomly allocated to either the MITD-LaC group or the control group (n = 32 per group). These patients will receive either MITD-LaC or incision and thread-drawing therapy. The design aims to allow for a robust comparison between the two treatment modalities. The primary endpoint is the wound healing time, while secondary endpoints include postoperative anal pain at 1, 3, and 5 days (measured with visual analogue scale), fecal incontinence score within 30 days after operation (measured with Cleveland Clinic Florida incontinence score), and the occurrence of postoperative complications within 1 month after surgery, and quality of life up to six months postoperatively (evaluated by The Quality of Life in patients with Anal Fistula Questionnaire Score). This study represents the first randomized controlled trial evaluating the short-term outcomes of MITD-LaC, thereby aiming to contribute high-quality evidence to guide clinical practice. Moreover, this trial incorporates comprehensive outcome measures assessing both subjective and objective dimensions. Because of this multidimensional assessment, MITD-LaC offers a promising potential for broader application in the treatment of HHAF. Consequently, obtaining more definitive and authoritative evidence through scientifically rigorous clinical trials is of utmost importance in further validating this treatment approach. We have submitted the clinical study protocol to the Ethics Committee, and it has been approved under ethical approval number 2021-1036-111-01. The results of the trial will be disseminated through peer-reviewed academic journals and presentations at professional conferences. ChiCTR2100053556.

Introduction and Hypothesis Guidelines recommend episiotomy for instrumental vaginal delivery with an optimal incision angle of 60° to protect the anal sphincter. The “Episiometer” is a new device promising a 60° incision angle. We compared the incidence of obstetric anal sphincter injury (OASI) and post-repair suture angle of episiotomies made with conventional “eyeballing” versus Episiometer guided during instrumental delivery. Methods We conducted this randomized controlled trial in a tertiary care teaching institute in southern India after ethical committee approval, trial registration, and informed consent. We randomized (block) 328 pregnant women aged 18 years and above with term, singleton fetuses delivered by instruments into Episiometer-guided (164) or conventional episiotomy (164) groups (allocation concealed). We compared the OASI (identified clinically) and the suture angle measured from the midline (assessor blinded) in the two groups. We followed up on the subjects at 6 and 12 weeks to assess perineal pain and fecal/flatus incontinence. Results The incidence of OASI of 0.61% in the Episiometer group was significantly lower compared with 4.88% in the eyeballing group (Chi-squared = 5.6; p  = 0.02; adjusted risk ratio = 5.9; CI 0.7–46.1; p = 0.09). A significantly higher proportion of subjects (59.1%) in the Episometer group had a post-suture angle between 36 and 40° compared with 36.6% in the eyeballing group (Chi-squared = 21.8, p  < 0.001). We found no significant difference in the perineal pain or Wexner score during follow-up. Conclusion The Episiometer-guided episiotomy during instrumental delivery resulted in a significantly higher suture angle and lower obstetric anal sphincter injuries than with conventional eyeballing.

IntroductionAs a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on quality of life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options.Methods and analysisThe objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of transanal irrigation (TAI) or sacral neuromodulation (SNM) compared with optimised conservative management (OCM) for people with major LARS.POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort design, with internal pilot phase, qualitative sub-study, process evaluation and economic evaluation. Approximately 1500 adult participants from UK hospitals and 500 from Australian hospitals who have undergone a high or low anterior resection for colorectal cancer in the last 10 years will be recruited into the cohort. Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted.The primary outcome measure of the POLARiS cohort and RCT is the LARS score up to 24 months post-registration/randomisation. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI versus OCM and SNM versus OCM. Secondary outcomes include health-related QoL, adverse events, treatment compliance and cost-effectiveness (up to 24 months post-registration/randomisation).Ethics and disseminationEthical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants on request and published on completion of the trial in a peer-reviewed journal and at international conferences.Trial registration numberISRCTN12834598; ACTRN12623001166662.

Introduction Obstetric anal sphincter injuries (OASI) are associated with significant risk of complications, including pain, infection, and long-term pelvic floor dysfunction. The primary aim of this study was to evaluate the utility and acceptability of a postpartum telehealth consultation focused on pelvic floor health for patients after OASI. Methods This prospective study used a pre–post design comparing standard postpartum care versus standard postpartum care plus a telehealth urogynecology consultation focused on pelvic floor recovery. The primary outcome was symptom burden as measured by the Pelvic Floor Distress Inventory (PFDI-20) score 16-weeks postpartum. Patient experience was evaluated using the QQ10 and the Patient Enablement Instrument. T -tests and chi-squared tests were used to compare groups. Results A total of 119 participants completed study activities (control group n  = 62, intervention group n  = 57). There was no significant difference between the two groups in PFDI-20 scores (55.6 versus 46.6, p  = 0.23). The individual items most likely to be endorsed among all participants were related to flatal incontinence (52.1%) and fecal urgency (49.6%). For the subset analysis of 35 patients with severe OASI (3C or fourth-degree tears), those who had a telehealth consultation had lower PFDI-20 scores (56.6 versus 34.7; p  = 0.04). QQ10 estimated a value score of 79/100 and a burden score of 18/100 for the telehealth consultation. Conclusions A postpartum telehealth consultation focused on pelvic floor health may benefit patients with severe OASI who reported reduced symptom burden. Participants rated a telehealth consultation as high value and low burden for this condition.

Poor bowel control is a major concern of people with inflammatory bowel disease (IBD). Previous research demonstrates the impact of fecal incontinence (FI) on adults in the non-IBD population; there are no previous reports on the experience of IBD-related FI. We randomly sampled 10,000 members of Crohn's & Colitis UK to receive a questionnaire to collect demographic information, medical history, continence status, quality of life, and free-text responses to questions about FI. Respondents could also choose to be interviewed about their experiences of living with IBD-related FI. This article presents findings from the free-text paper questionnaire responses and the interviews. Following transcription, data were sorted and analyzed using a pragmatic thematic approach. We received 3264 eligible replies (32.6%). Twenty-eight interviews and 583 sets of questionnaire data were transcribed, continuing with the latter until no new themes emerged. The remaining questionnaires (n = 2681) were read to check that no issues had been missed. Several core themes emerged: emotional and psychological impact, feelings of stigma, limited lives, symptoms, practical coping mechanisms, access to facilities, and fear of incontinence. Incontinence, and fear of it, limits social, working, and personal lives, impacting on people with IBD in complex ways. Key strategies, including situation avoidance and dietary restrictions, are used to cope. Incontinence is degrading and humiliating for most people, although a small number approach their situation positively. IBD-related FI, and fear of incontinence, causes multiple difficulties. People with IBD-related FI need help in accessing professional support.