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ObjectiveStress urinary incontinence (SUI) is common among females during functional fitness training, such as CrossFit. The aim of this study was to assess the effect of pelvic floor muscle training (PFMT) on SUI in female functional fitness exercisers.MethodsThis was an assessor-blinded randomised controlled trial with a PFMT group (n=22) and a control group (n=25). The PFMT group followed a 16-week home-training programme with 3 sets of 8–12 maximum pelvic floor muscle (PFM) contractions daily and weekly follow-up/reminders by phone. The primary outcome was change in a total score of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). The secondary outcomes were perceived change of symptoms of SUI, change of PFM strength measured by vaginal manometry and symptoms of anal incontinence (AI) and pelvic organ prolapse (POP).Results47 women, mean age of 33.5 years (SD: 8.1), participated. At 16 weeks, there was a mean difference between groups of −1.4 (95% CI: −2.6 to −0.2) in the change of the ICIQ-UI-SF score in favour of the PFMT group. The PFMT group completed a mean of 70% (SD: 23) of the prescribed protocol. 64% in the PFMT group versus 8% in the control group reported improved symptoms of SUI (p<0.001, relative risk: 7.96, 95% CI, 2.03 to 31.19). There were no group differences in the change of PFM strength or AI/POP symptoms.ConclusionA 16-week home-training programme of the PFM led to improvements in SUI in female functional fitness exercisers. However, PFM strength and AI and POP symptoms did not improve significantly in the PFMT group compared with the control group.

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.

Introduction and Hypothesis Standardized digital rectal examination (DRE) correlates with anorectal manometry (ARM) measures. However, less is known about the relationship between DRE/ARM measures and patient-reported outcomes (PROs), especially among women with fecal incontinence (FI). Our aims were to evaluate associations between DRE and ARM measures and compare PROs with diagnostic evaluation measures for women with FI. Methods We analyzed data from the parent clinical trial, Controlling Anal incontinence by Performing Anal exercises with Biofeedback or Loperamide (CAPABLe). We pooled data from randomized women who completed standardized ARM, DRE, and validated PROs at baseline and 12 and 24 weeks post-treatment initiation. PROs included FI severity, impact on quality of life, and bowel diary data. We analyzed ARM pressure and volume data and DRE using the Digital Rectal Examination Scoring System (DRESS) resting and squeeze mean scores. We used Spearman Rank Correlation to measure associations between the ARM measures and mean DRESS scores, and between PROs and ARM/DRESS scores. Results Among 291 randomized women with ARM and DRE data, the correlation between DRESS and ARM resting measures was 0.196 ( p <0.001) and between squeeze measures was 0.247 ( p <0.001). At most timepoints, PROs more consistently correlated with squeeze ARM pressures and squeeze DRESS scores than resting measures. Conclusions We found weak correlations between ARM and DRE measures and between those measures and PROs. Although DRE and ARM are commonly used diagnostic measures among women with FI, the weak correlations with patient-reported symptoms raises questions about their utility in clinical care.

Background Fecal incontinence (FI) is a prevalent condition affecting 2% to 21% of the general population, with higher rates in older adults and specific settings such as nursing homes and hospitals. Current treatments include supportive care, biofeedback, anal injections, and sacral nerve stimulation, though these can be invasive or costly. Pharmacological therapies, like stool bulking agents and constipating agents, help manage symptoms but can have side effects. Ramosetron, a 5-HT3 receptor antagonist, shows promise for FI treatment by reducing intestinal motility and improving stool consistency. This study aims to compare the effectiveness and safety of ramosetron (Irribow ® ) and psyllium (AGIO ® ) in treating FI in a randomized, parallel, non-inferiority trial. Methods This study will include adults aged 19 years and above who are diagnosed with FI. Participants will be randomly assigned to receive either ramosetron (5 μg for males, 2.5 μg for females) or psyllium (6 g) once daily. The primary endpoint will compare changes in Fecal Incontinence Severity Index (FISI) scores before and after medication. Secondary endpoints will include comparisons of FISI scores, Fecal Incontinence Quality of Life (FIQL) scores, patient satisfaction surveys, and Bristol Stool Scale scores between the two groups. Follow-up visits will take place at baseline and at 1, 4, and 12 months to assess symptoms and administer surveys. The primary endpoint is the within-group improvement in FISI scores, while the secondary endpoint is a between-group non-inferiority comparison of ramosetron versus psyllium. A sample size of 56 participants is needed for statistical significance at the 0.05 level with 80% power, accounting for dropout, for a total of 148 participants. Discussion It is believed that 5-HT3 receptor antagonists, along with Psyllium, can improve bowel habits and alleviate symptoms, thereby enhancing the quality of life for patients with FI. Trial registration ClinicalTrials.gov NCT06166615, December 12, 2023.

Background After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50–80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment. Methods The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes. Discussion The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial. Trial registration Netherlands Trial Registration, NTR5469 , registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.

Background Low anterior resection syndrome (LARS) is a distressing condition that affects approximately 25–80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT). Methods and analysis In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months). Discussion We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery. Trial registration Chinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.

Background Anal sphincter defects are a major cause of fecal incontinence causing negative effects on daily life, social interactions, and mental health. Because human adipose-derived stromal/stem cells (hADSCs) are easier and safer to access, secrete high levels of growth factor, and have the potential to differentiate into muscle cells, we investigated the ability of hADSCs to improve anal sphincter incontinence. Methods The present randomized double-blind clinical trial was performed on patients with sphincter defects. They were categorized into a cell group ( n  = 9) and a control group ( n  = 9). Either 6 × 10 6 hADSCs per 3 ml suspended in phosphate buffer saline (treatment) or 3 ml phosphate buffer saline (placebo) was injected. Two months after surgery, the Wexner score, endorectal sonography, and electromyography (EMG) results were recorded. Results Comparing Wexner scores in the cell group and the control group showed no significant difference. In our EMG and endorectal sonography analysis using ImageJ/Fiji 1.46 software, the ratio of the area occupied by the muscle to total area of the lesion showed a 7.91% increase in the cell group compared with the control group. Conclusion The results of the current study show that injection of hADSCs during repair surgery for fecal incontinence may cause replacement of fibrous tissue, which acts as a mechanical support to muscle tissue with contractile function. This is a key point in treatment of fecal incontinence especially in the long term and may be a major step forward. Trial registration Iranian Registry of Clinical Trials IRCT2016022826316N2 . Retrospectively registered 7 May 2016.

The objective of this study was to show that although transcutaneous electrical tibial nerve stimulation (TENS) is being increasingly used to treat fecal incontinence (FI), its efficacy has never been proved using controlled trials. In this randomized, double-blind, sham-controlled trial, 144 patients aged 30-82 years from nine centers were randomly assigned to receive either active or sham stimulations for 3 months. The primary end point was the response to treatment based on the number of incontinence and urgency episodes. Secondary end points were severity scores, quality of life scores, delay to postpone defecation, patient self-assessment of treatment efficacy, physician assessment of TENS efficacy, anorectal manometry, and adverse events. No statistically significant difference was seen between active and sham TENS in terms of an improvement in the median number of FI/urgency episodes per week. Thirty-four patients (47%) who received the active TENS treatment exhibited a >30% decrease in the FI severity score compared with 19 patients (27%) who received the sham treatment (odds ratio 2.4, 95% confidence interval 1.1-5.1, P=0.02). No differences in delay to postpone defecation, patient self-assessment of treatment efficacy, or anorectal manometry were seen between the two groups. The evaluating physicians rated the active stimulations as more effective than the sham stimulations (P=0.01). One minor therapy-related adverse event was observed (1.5%) (see Supplementary Consort 1b). We failed to demonstrate any benefit of TENS on our primary end-point.

Introduction and hypothesis This study aims to assess the responsiveness and interpretability of the Vaizey score, Wexner score, and the Fecal Incontinence Quality of Life Scale (FIQL) for use in the evaluation of patients with fecal incontinence (FI). Methods Eighty patients with FI with a mean age of 59.3 (SD ± 11.9) were enrolled in a randomized controlled trial. The patient-reported outcomes were tested for internal and external responsiveness, longitudinal construct validity, and interpretability. Results All total scores proved to have both adequate to excellent responsiveness and longitudinal construct validity, and changes were in agreement with subjective improvement. Due to variability in minimally important change estimates (Vaizey score −5 to −3, Wexner score −3 to −2, FIQL 1.1 to 1.2), they should be used as indicators. All patient-reported outcomes showed psychometric or practical limitations. Conclusions The instruments available to date to evaluate severity and quality of life in FI do not yet attain the highest levels of psychometric soundness. As the focus of patients may differ from that of physicians, it is recommended that several measures should be included for evaluation. So far, there are suggestions that the Wexner score is most suitable for severity assessment and the FIQL for evaluating quality of life.

Background Faecal incontinence (FI) is a substantial health problem with a prevalence of approximately 8% in community-dwelling populations. Sacral neuromodulation (SNM) is considered the first-line surgical treatment option in adults with FI in whom conservative therapies have failed. The clinical efficacy of SNM has never been rigorously determined in a trial setting and the underlying mechanism of action remains unclear. Methods/design The design encompasses a multicentre, randomised, double-blind crossover trial and cohort follow-up study. Ninety participants will be randomised to one of two groups (SNM/SHAM or SHAM/SNM) in an allocation ratio of 1:1. The main inclusion criteria will be adults aged 18–75 years meeting Rome III and ICI definitions of FI, who have failed non-surgical treatments to the UK standard, who have a minimum of eight FI episodes in a 4-week screening period, and who are clinically suitable for SNM. The primary objective is to estimate the clinical efficacy of sub-sensory SNM vs. SHAM at 32 weeks based on the primary outcome of frequency of FI episodes using a 4-week paper diary, using mixed Poisson regression analysis on the intention-to-treat principle. The study is powered (0.9) to detect a 30% reduction in frequency of FI episodes between sub-sensory SNM and SHAM stimulation over a 32-week crossover period. Secondary objectives include: measurement of established and new clinical outcomes after 1 year of therapy using new (2017 published) optimised therapy (with standardised SNM-lead placement); validation of new electronic outcome measures (events) and a device to record them, and identification of potential biological effects of SNM on underlying anorectal afferent neuronal pathophysiology (hypothesis: SNM leads to increased frequency of perceived transient anal sphincter relaxations; improved conscious sensation of defaecatory urge and cortical/subcortical changes in afferent responses to anorectal electrical stimulation (main techniques: high-resolution anorectal manometry and magnetoencephalography). Discussion This trial will determine clinical effect size for sub-sensory chronic electrical stimulation of the sacral innervation. It will provide experimental evidence of modifiable afferent neurophysiology that may aid future patient selection as well as a basic understanding of the pathophysiology of FI. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN98760715 . Registered on 15 September 2017.