Fecal Incontinence Quality Of Life Research Articles

Efficacy of Pelvic Floor Muscle Training for Postoperative Patients With Rectal Cancer: A Systematic Review and Meta-Analysis.

This study aimed to assess the effectiveness of pelvic floor muscle training (PFMT) for fecal incontinence (FI) and health-related quality of life (HR-QOL) after colorectal cancer surgery. This systematic review (SR) and meta-analysis included randomized controlled trials (RCTs) that examined the effects of PFMT after colorectal cancer surgery, which were extracted from several databases in January 2023. The primary outcomes were FI (Wexner scores), HR-QOL, and adverse events. We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to assess the certainty of evidence (CoE). A total of seven RCTs were included. Our SR results suggested that PFMT showed little to no difference in FI (mean difference 0.62 higher; 95% CI: -1.26 to 2.5, low CoE) and adverse events (risk ratio 5.78; 95% CI: 0.28-117.22, low CoE). Two adverse events occurred in the PFMT group (anastomotic stenosis, suboptimal use of laxatives) and were not observed in controls. HR-QOL was measured in two RCTs using 12-item Short Form Survey (SF-12) and fecal incontinence quality of life (FIQL). Two RCTs found no trend toward a positive impact on HR-QOL. Higher quality RCTs on colorectal cancer after surgery are required. Furthermore, extending the duration of the PFMT intervention may be necessary to ensure its success.

Effectiveness and safety of digital rectal stimulation and abdominal massage for neurogenic bowel dysfunction in stroke patients: a randomized controlled trial protocol

BackgroundNeurogenic bowel dysfunction (NBD) is a prevalent complication among stroke patients, significantly affecting their quality of life, duration of hospitalization, medical expenses, and even mortality. Although current guidelines suggest a conservative strategy for addressing bowel dysfunction, which includes techniques such as digital rectal stimulation (DRS) and abdominal massage, the availability of interventions remains limited in healthcare facilities.MethodsThis study follows a prospective randomized controlled parallel-group clinical trial design. The control group will receive standard care, while the intervention group will undergo a program that combines DRS and abdominal massage in addition to standard care. The duration of the intervention for both groups will be 6 weeks. The primary outcome measures will be the Wexner score. Furthermore, secondary outcomes measure will be assessed, including Bristol score, Patient Assessment of Constipation-Quality of Life (PAC-QoL), and Fecal Incontinence Quality of Life (FI-QoL).DiscussionThis study aims to evaluate the effectiveness and safety of a bowel rehabilitation program for stroke patients with NBD. The findings will provide information that can contribute to the formulation of bowel management strategies.Trial registrationThe study has been registered in the Chinese Clinical Registry under the number ChiCTR2300071709. This registration was completed on May 23, 2023. All items from the World Health Organization Trial Registration Data set are described in this manuscript.

Comparison of long-term quality of life based on surgical procedure in patients with rectal cancer.

Reports on the long-term quality of life (QOL) over 3 years after surgery in patients who have undergone surgery for rectal cancer are limited. Therefore, we aimed to evaluate the long-term QOL of patients who underwent high anterior resection (HAR), low anterior resection (LAR), internal sphincter resection (ISR), or abdominoperineal resection (APR) for rectal cancer. A questionnaire regarding QOL was sent to 360 patients with rectal cancer who underwent curative resection by HAR, LAR, ISR, or APR between January 2005 and December 2015. QOL was assessed using the short-form 36 (SF-36) and modified fecal incontinence QOL (mFIQL) questionnaire. QOL between surgical procedures was analyzed using a multivariate model adjusted for age, sex, and postoperative time. A total of 144 patients responded with a median follow-up period of 94 months (range 38-233 months). According to surgical procedure, HAR was performed in 26 patients, LAR in 80 patients, ISR in 32 patients, and APR in 6 patients. Patients who underwent HAR had significantly better mFIQL scores than those who underwent LAR and ISR (p=0.013 and p=0004, respectively) and significantly better role/social component summary scores on the SF-36 subscales (p=0.007). No difference was observed in the mFIQL scores between patients who underwent ISR and those who underwent APR (p=0.8423). In addition, postoperative anastomotic leakage sutures did not influence the mFIQL and SF-36 scores after surgery. The QOL of patients who underwent anus-preserving surgery was best in the HAR group, with the QOL of other groups similar to the APR group. These results suggest that anus- preserving surgery is acceptable from a QOL standpoint. However, a colostomy may be a more satisfactory procedure in some patients.

Patient-reported Bowel Function and Bowel-related Quality of Life After Pelvic Radiation for Rectal Adenocarcinoma: The Impact of Radiation Fractionation and Surgical Resection

IntroductionMultimodality treatment for locally advanced rectal cancer (LARC) can include long-course radiotherapy (LCRT) or short course radiotherapy (SCRT). Nonoperative management is increasingly pursued for those achieving a complete clinical response. Data regarding long-term function and quality-of-life (QOL) are limited. MethodsPatients with LARC treated with radiotherapy from 2016 to 2020 completed the Functional Assessment of Cancer Therapy- General (FACT-G7), the Low Anterior Resection Syndrome Score (LARS) and the Fecal Incontinence QOL Scale (FIQOL). Univariate and multivariable linear regression analyses identified associations between clinical variables including radiation fractionation and the use of surgery versus non-operative management. ResultsOf 204 patients surveyed, 124 (60.8%) responded. Median (interquartile range) time from radiation to survey completion was 30.1 (18.3-43) months. Seventy-nine (63.7%) respondents received LCRT, and 45 (36.3%) received SCRT; 101 (81.5%) respondents underwent surgery, and 23 (18.5%) pursued nonoperative management. There were no differences in LARS, FIQoL or FACT-G7 between patients receiving LCRT versus SCRT. On multivariable analysis, only nonoperative management was associated with lower LARS score signifying less bowel dysfunction. Nonoperative management and female sex were associated with a higher FIQoL score signifying less disruption and distress from fecal incontinence issues. Finally, lower BMI at the time of radiation, female sex, and higher FIQoL score were associated with higher FACT-G7 scores signifying better overall QOL. ConclusionsThese results suggest long-term patient-reported bowel function and QOL may be similar for individuals receiving SCRT and LCRT for the treatment of LARC, but nonoperative management may lead to improved bowel function and QOL.

Annual long-term functional outcomes after transanal repair for symptomatic rectocele.

This study was performed to assess the long-term annual functional outcomes and quality of life (QOL) after transanal rectocele repair. We evaluated retrospectively collected data from patients who underwent transanal repair for symptomatic rectocele between February 2012 and December 2018. The Constipation Scoring System (CSS), the Fecal Incontinence Severity Index (FISI), and several QOL questionnaires (e.g., the Patient Assessment of Constipation-QOL [PAC-QOL], Fecal Incontinence QOL, and the 36-Item Short Form Survey [SF-36]) were administered before surgery and annually after surgery. Additionally, physiological assessments and defecography were performed before and after surgery. Substantial symptom improvement, indicated by at least a 50% reduction in the CSS or FISI score, was evaluated postoperatively. All postoperative follow-up results were compared with the preoperative data. Thirty-two patients were included in the study. The median follow-up period was 5 years (range, 0.5-7 years). Postoperative defecography showed that the rectocele size significantly decreased (P<0.0001). However, the physiological assessment did not reveal postoperative changes. The CSS score 1 year after surgery was significantly lower than the preoperative score (P<0.0001) and remained significantly low until the long-term follow-up. Constipation improved by more than 80% 2 to 5 years postoperatively, and fecal incontinence improved in 2/3 of the patients after 5 years. The PAC-QOL scores significantly improved (all P<0.05) over time until the 3-year and long-term follow-ups, and 6 of the 8 SF-36 scores significantly improved at specific points postoperatively. Transanal rectocele repair provides long-term improvement for constipation and constipation-specific QOL.

Does transanal endoscopic microsurgery affect rectal function?

Transanal endoscopic microsurgery (TEM) is the most standardized method for the local excision of rectal neoplasms. Unfortunately, local excisions of rectal lesions by means of TEM are not completely free from undesirable functional sequela. This study was performed to evaluate the risk factors of major loss of function after TEM. Eighty-nine patients underwent TEM between 2019 and 2020. Anorectal manometry was performed before the surgery and 3, 6, and 12 months after the surgery. The quality of life (QoL) was assessed using the Fecal Incontinence Quality of Life scale. The major decrease in QoL was observed in women in 3 months after the surgery in terms of lifestyle and frustration domains (3.6 and 3.64 points, respectively). In 3 months after the surgery, there was a significant decrease in resting pressure both in male and female patients (P=0.01). This difference remained significant 6 months after the surgery (P=0.01). In 12 months after the surgery, resting pressure returned to the preoperative level in most patients (P=0.50). A significant decrease in manometric parameters appeared when the surgery time is more than 55 minutes (P=0.05), the tumor localization is lower than 3 cm from the anus (P=0.03), and the tumor size is over 3 cm (P=0.001). The most significant risk factors for the development of functional disorders after TEM are surgery time of >55 minutes, tumor localization at <3 cm from the anal verge, and tumor size of >3 cm.

Ventral Pelvio-anal Reconstruction as a Variation of Established Surgical Management of Severe and Refractory Fecal Incontinence: A Case Series Study

Background: Conventional treatments may not be effective in some severe cases of fecal incontinence (FI). Objectives: In the present study, we evaluated the applicability of ventral pelvio-anal reconstruction (VPAR) as a modified operative technique for 17 patients with severe and refractory FI. Methods: We performed VPAR by placing a mesh in the perineum and securing it at the sacrospinal ligament on both sides. The Cleveland Clinic Incontinence Score (CCIS) and Fecal Incontinence Quality of Life (FIQoL) questionnaires were completed by the patients, and anorectal manometry was performed before and after the operation (3,6 and 12 months), and the results were compared against the baseline values. Results: The operation was successful in all patients; no mesh was explanted during the follow-up period, and all patients reported satisfactory outcomes. Postsurgical anorectal manometry showed an increase in both rest and squeeze pressures. The CCIS decreased while the FIQoL increased significantly during the first-year follow-up (P &lt; 0.001). Conclusions: By incorporating the implant into the perineal body, we hypothesized that our combined technique would lead to favorable outcomes, and the preliminary results confirmed this. Further studies with larger patient populations and more extended follow-up periods are needed to confirm our satisfactory results and conclude that the VPAR approach is a safe and appropriate therapeutic option for patients with severe and refractory FI.

Skeletal Muscle–Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study

Fecal incontinence (FI) improvement following injection of autologous skeletal muscle-derived cells has been previously suggested. This study aimed to test the efficacy and safety of said cells through a multicenter, placebo-controlled study, to determine an appropriate cell dose, and to delineate the target patient population that can most benefit from cell therapy. Patients experiencing FI for at least 6 months were randomized to receive a cell-free medium or low or high dose of cells. All patients received pelvic floor electrical stimulation before and after treatment. Incontinence episode frequency (IEF), FI quality of life, FI burden assessed on a visual analog scale, Wexner score, and parameters reflecting anorectal physiological function were all assessed for up to 12 months. Cell therapy improved IEF, FI quality of life, and FI burden, reaching a preset level of statistical significance in IEF change compared with the control treatment. Post hoc exploratory analyses indicated that patients with limited FI duration and high IEF at baseline are most responsive to cells. Effects prevailed or increased in the high cell count group from 6 to 12 months but plateaued or diminished in the low cell count and control groups. Most physiological parameters remained unaltered. No unexpected adverse events were observed. Injection of a high dose of autologous skeletal muscle-derived cells followed by electrical stimulation significantly improved FI, particularly in patients with limited FI duration and high IEF at baseline, and could become a valuable tool for treatment of FI, subject to confirmatory phase 3 trial(s). (ClinicalTrialRegister.eu; EudraCT Number: 2010-021463-32).

An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence

BackgroundImplantation of Gatekeeper™ prostheses presents an option for the treatment of passive faecal incontinence (FI). Whilst preliminary results are encouraging, long-term data regarding its sustained benefit are limited. The aim of this study was to assess and evaluate the long-term clinical function and quality of life of patients with passive faecal incontinence who were treated with Gatekeeper™ prostheses.MethodsThis was a single centre, single surgeon retrospective study of prospectively collected clinical data in patients with FI treated between June 2012 and May 2019. Patients with passive FI with symptoms refractory to conservative treatment and endoanal ultrasonography showing intact or disrupted internal anal sphincter were included. Formal clinical and quality of life assessments were carried out using the St. Mark’s Incontinence Score (SMIS) and Faecal Incontinence Quality of Life (FIQoL) questionnaires at baseline, 3 months, 6 months, 12 months and then annually. Endoanal ultrasonography was performed both before and after surgery.ResultsForty patients (14 males, 26 females) with a median age of 62.5 (range 33–80) years were treated with the Gatekeeper™ implant. The majority of patients (87.5%) received six implants. There were no peri or post-operative complications. Prosthesis migration was observed in 12.5% patients. The median follow-up duration was 5 years (interquartile range (IQR) 3.25–6.00 years). A sustained improvement in median SMIS and FIQoL scores from baseline to follow-up was noted. Significant differences were observed between the median baseline SMIS score and last follow-up score of 16.00 (IQR 15.00–16.75) to 7.00 (IQR 5.00–8.00) respectively (p < 0.001), a 56.25% decrease. The overall median FIQoL score showed a significant improvement from 7.95 (IQR 7.13–9.48) to 13.15 (IQR 12.00–13.98) (p < 0.001) a 65.40% increase.ConclusionsGatekeeper™ implantation is a safe approach to treating passive FI and is minimally invasive, reproducible and has minimal complications. Long-term sustained clinical improvement is achievable beyond 5 years. Careful patient selection is paramount, as is consistency of technique and follow-up protocol.

Patient-Reported Bowel and Urinary Function in Long-Term Survivors of Squamous Cell Carcinoma of the Anus Treated With Definitive Intensity Modulated Radiation Therapy And Concurrent Chemotherapy

Definitive radiation therapy with concurrent chemotherapy is curative for nonmetastatic squamous cell carcinoma of the anus (SCCA). However, the true effect of chemoradiation on long-term functional outcomes is poorly understood owing to limited follow-up and patient-reported outcomes (PROs). We conducted a cross-sectional survey of 248 patients with SCCA treated with definitive intensity modulated radiation and concurrent chemotherapy from 2010 to 2018 who were alive and without recurrence. PRO measures were collected, including Functional Assessment of Cancer Therapy-General (FACT-G7), Fecal Incontinence Quality of Life (FIQoL), Low Anterior Resection Syndrome (LARS), and International Consultation on Incontinence Questionnaires (ICIQ). Models were used to determine the association between demographic, tumor, treatment, and dosimetric data with PROs. One hundred twelve (45%) patients completed PROs. Median [interquartile range (IQR)] time from radiation completion to survey was 51 [37-85] months. The median scores [IQR] for FACT-G7, FIQoL, and LARS were 21 [15-24], 14 [11-16], and 32 [25-37], respectively. For men, median subscores [IQR] for ICIQ voiding and incontinence subscores were 5 [2-6] and 1 [1-3], respectively. For women, median subscores [IQR] for ICIQ voiding, incontinence, and filling were 1 [1-3], 5 [3-8], and 4 [2-5], respectively. Higher (better) FIQoL scores were associated with higher (better) FACT-G7 scores (β=0.83; 95% confidence interval, 0.58-1.09; P < .001), and higher (worse) LARS scores were associated with lower (worse) FACT-G7 scores (β=-0.22; 95% confidence interval, -0.31 to -0.13; P < .001). A separate multivariable analysis revealed higher bowel bag D1% was associated with lower (worse) FIQoL (P=.001) and higher (worse) LARS (P=.003) scores. Higher bladder V40 Gy was associated with increased (worse) ICIQ voiding subscore (P=.001). Patients treated with modern chemoradiation for SCCA experience significant long-term bowel toxic effects with considerable effect on quality of life. Minimizing bowel hotspots and bladder V40 Gy may improve bowel and urinary function. Other interventions to reduce long-term toxic effects and improve quality of life are needed.

Robotic surgery contributes to the preservation of bowel and urinary function after total mesorectal excision: comparisons with transanal and conventional laparoscopic surgery

BackgroundDetermine whether robotic surgery is more effective than transanal and conventional laparoscopic surgery in preserving bowel and urinary function after total mesorectal excision (TME).MethodsOf 79 lower rectal cancer patients who underwent function-preserving TME between 2016 and 2020, 64 patients consented to a prospective questionnaire-based functional observation study (52 responded). At 6 months post-resection or ileostomy closure, Wexner, low anterior resection syndrome (LARS), modified fecal incontinence quality of life, and international prostate symptom scores were used to evaluate bowel and urinary function, comparing robotic surgery (RTME) with transanal (taTME) or conventional laparoscopic surgery (LTME).ResultsRTME was performed in 35 patients (54.7%), taTME in 15 (23.4%), and LTME in 14 (21.9%). While preoperative bowel/urinary functions were similar in all three procedures, and the distance from the anal verge to tumor was almost the same, more hand-sewn anastomoses were performed and the anastomotic height from the anal verge was shorter in taTME than RTME. At 2 years post-resection, 8 patients (12.5%) had a permanent stoma; RTME showed a significantly lower rate of permanent stoma than taTME (2.9% vs. 40%, p < 0.01). Despite no significant difference, all bowel function assessments were better in RTME than in taTME or LTME. Major LARS was observed in all taTME and LTME cases, but only 78.8% of RTME. No clear difference arose between RTME and taTME in urinary function; urinary dysfunction was more severe in LTME than RTME (36.4% vs. 6.1%, p = 0.02).ConclusionsIn function-preserving TME for lower rectal cancer, robotic surgery was suggested to be more effective than transanal and conventional laparoscopic surgery in terms of bowel and urinary functions.

Sphincter-Preserving Fistulectomy Is an Effective Minimally Invasive Technique for Complex Anal Fistulas.

BackgroundThe optimal treatment of complex anal fistulas remains unclear, though many different sphincter-preserving procedures have been described. A minimally invasive technique with a better outcome is desired. The purpose of this study was to present a new technique—sphincter-preserving fistulectomy (SPF) and its clinical outcomes.Materials and MethodsA retrospective study was performed to compare the efficacy and outcomes of SPF with ligation of the intersphincteric fistula tract (LIFT) in the management of complex anal fistulas in regards to postoperative pain, complications, wound healing time, recurrence, overall success rate, fecal continence function, and quality of life. Continence function was evaluated using the Wexner incontinence scale and anal manometry. The fecal incontinence quality of life (FIQL) scale was used to assess patients' quality of life.ResultsFrom June 2020 to July 2021, 41 patients with 43 SPF procedures and 35 patients with 35 LIFT procedures were included. Postoperative pain was comparable between two groups. The morbidity rate and the mean wound healing time in the SPF group were lower than those in the LIFT group (2.3% vs. 48.6%, p < 0.001; 1.4 ± 0.3 vs. 1.7 ± 0.4 months, p = 0.001). At a mean follow-up duration of 11.4 ± 3.5 months in the SPF group and 10.7 ± 4.3 months in the LIFT group, SPF achieved a better overall success rate than LIFT (97.7% vs. 77.1%, p = 0.014). Three patients in the SPF group and 4 patients in the LIFT group who all underwent a simultaneous fistulotomy procedure complained new incontinence of flatus. There was no statistical difference between the two groups in regards to the Wexner scores (p = 0.790), the maximum resting anal canal pressure (p = 0.641), the maximum squeeze pressure (p = 0.289), and the FIQL scores including lifestyle (p = 0.188), coping (p = 0.188), depression (p = 0.850), and embarrassment (p = 0.910).ConclusionsSPF is a novel, safe, and effective minimally invasive technique for the management of complex anal fistulas, with a promising success rate and negligible impairment on continence. Future prospective studies are needed to evaluate the long-term outcomes of SPF.

Association between Fecal Incontinence and Lower Urinary Tract Symptoms and their Impact on the Quality of Life of Patients with Prostate Cancer

Abstract Objective To evaluate the association of fecal incontinence (FI) and lower urinary tract symptoms (LUTS) in patients diagnosed with initial prostate cancer (PC) and after any therapeutic approach (surgery and radiotherapy). Methods Cross-sectional study using the Cleveland Clinic Incontinence Score (CCIS), the Fecal Incontinence Quality of Life (FIQL) questionnaire, and the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Results A total of 84 patients with PC were included: 40 of them had not started treatment, 31 were submitted to radical prostatectomy (RP), and 13 were submitted to radiotherapy (RT). Those submitted to RT presented higher scores on the ICIQ-OAB (p = 0.01). When comparing the whole sample reagarding the patients with and without FI, we observed that the incontinents presented a higher frequency of urinary incontinence (UI) (p &lt; 0.001). Moreover, when comparing patients with/without FI within their treatment groups regarding the presence of UI and FIQL scores, we identified that patients undergoing RP presented an association between UI and FI (p &lt; 0.001) and a greater impact of FI on the FIQL (p &lt; 0.001). Conclusion Patients submitted to RT present more intense LUTS. Moreover, patients with FI present a higher association with UI, and this association is more marked in those with FI submitted to RP.

The Minimal Important Difference of the Fecal Incontinence Quality of Life (FIQL) Questionnaire for Patients with Posterior Compartment Prolapse: A Prospective Cohort Study.

Objectives: The minimally important difference (MID) of the Fecal Incontinence Quality of Life (FIQL) scale has never been determined. Thus, in this study, we aimed to estimate the MID of the Japanese FIQL for patients with posterior compartment prolapse (PCP). Methods: For 3-months after surgery, we followed a prospective cohort of 136 patients with PCP combined with fecal incontinence (FI) who had undergone ventral rectopexy between 2012 and 2018. Usable data from 114 patients were analyzed. Patients have both completed the FIQL and the 36-Item Short Forum Health Survey (SF-36) before and after surgery. Distribution-based MID values were estimated at 1/2 SD and the standard error of measurement (SEM) for domain and total scores across time points. Changes in the domain scores anchored to changes in a SF-36 overall health assessment question were used to estimate anchor-based MID. To be interpreted as true change, the median, anchor-based MID values that were greater than the corresponding SEM were proposed as estimates of the MID for the FIQL. Results: Distribution-based MID of 1/2 SD for each domain and total score ranged between 0.3 and 0.4, whereas SEM ranges were between 0.2 and 0.3. The anchor-based approach resulted in the median MID estimates of 0.4 to 1.0. Final estimates of MID for each FIQL and total score were as follows: lifestyle (0.6-1.1), coping/behavior (0.8-1.4), depression/self-perception (0.4-0.8), embarrassment (1.0-1.6), and total score (0.7-1.1). Conclusions: The results provide a basis for clinically important differences in FIQL scores after surgery for patients with PCP and FI.

P585 Examining faecal incontinence and its impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a multi-country burden of illness study

Abstract Background Perianal fistulas (PAF) are a common complication associated with Crohn’s disease (CD), and patients with Crohn’s perianal fistulas (CPF) are more likely to experience faecal incontinence (FI) than patients with CD without PAF (non-PAF CD). A global study was conducted to assess the burden of illness in patients with CPF compared with patients with non-PAF CD. Here, we present data on the level of FI and its impact on quality of life (QoL). Methods This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort 1) or CPF without PAF-related surgery (cohort 2) or CPF with PAF-related surgery (cohort 3). Validated, general and disease-specific patient-reported outcome data were collected using a 45-min IRB/EC-approved web-enabled questionnaire. The level of FI was evaluated using the Revised Faecal Incontinence Score (RFIS) (1–20 scale, 0 = no incontinence, 4-week recall period) and the impact of FI on QoL in patients who had experienced FI using the Fecal Incontinence Quality of Life (FIQL) (1–5 scale, 1 = lower QoL). Data were analysed using descriptive statistics. Results Of the 929 patients recruited (cohort 1, n = 620; cohort 2, n = 174; cohort 3, n = 135), 58–69% were male and 55–67% were aged 21–40 years across all cohorts. A significantly higher proportion of patients in cohort 3 than cohort 1 had severe Crohn’s disease as classified by a physician (18% vs 9%, respectively; p &amp;lt; 0.05). Overall, 47% of patients reported experiencing FI and completed both the RFIS and FIQL. Significantly higher proportions of patients in cohorts 2 and 3 had experienced FI than in cohort 1 (59% and 59% vs 40%, respectively; p &amp;lt; 0.05), and a significantly higher proportion were currently experiencing FI in cohort 3 than in cohorts 1 and 2 (69% vs 37% and 45%, respectively; p &amp;lt; 0.05). Mean RFIS scores were significantly higher (worse) in cohorts 2 and 3 than cohort 1 (9.5 [p &amp;lt; 0.05] and 10.6 [p &amp;lt; 0.001] vs 8.2, respectively). Patients in cohort 2 had significantly lower (worse) FIQL scores than those in cohort 1 across three FIQL domains (lifestyle [2.2 vs 2.4], depression/self-perception [2.1 vs 2.3], embarrassment [2.2 vs 2.4]; p &amp;lt; 0.05), whereas patients in cohort 3 only reported significantly lower FIQL scores compared with cohort 1 in the embarrassment domain (2.2 vs 2.4; p &amp;lt; 0.05). Conclusion In this study almost half of the patients experienced faecal incontinence. Among those who experienced faecal incontinence, patients with PAF experienced a significantly higher impact on their quality of life compared with patients without PAF.

A Randomized Pilot Study to Compare the Effectiveness of a Low FODMAP Diet vs Psyllium in Patients With Fecal Incontinence and Loose Stools.

INTRODUCTION:The aim of the study was to compare the effectiveness of a low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol diet (LFD) vs psyllium on the frequency and severity of fecal incontinence (FI) episodes in patients with loose stools.METHODS:This was a single-center, randomized pilot trial of adult patients with FI (Rome III) with at least 1 weekly FI episode associated with loose stool. Eligible patients were randomized to 4 weeks of either a dietitian-led LFD or 6 g/d psyllium treatment.RESULTS:Forty-three subjects were randomized from October 2014 to May 2019. Thirty-seven patients completed the study (19 LFD and 18 psyllium). There was no statistically significant difference in the proportion of treatment responders (>50% reduction in FI episodes compared with baseline) for treatment weeks 1–4 (LFD 38.9%, psyllium 50%, P = .33). Compared with baseline, mean fecal incontinence severity index score significantly improved with LFD (39.4 vs 32.6, P = .02) but not with psyllium (35.4 vs 32.1, P = .29). Compared with baseline values, the LFD group reported improvements in fecal incontinence quality of life coping/behavior, depression/self-perception, and embarrassment subscales. The psyllium group reported improvement in incontinence quality of life coping/behavior.DISCUSSION:In this pilot study, there was no difference in the proportion of patients who reported a 50% reduction of FI episodes with the LFD or psyllium. Subjects in the psyllium group reported a greater reduction in overall FI episodes, whereas the LFD group reported consistent improvements in FI severity and quality of life. Further work to understand these apparently discrepant results are warranted but the LFD and psyllium seem to provide viable treatment options for patients with FI and loose stools.

Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study.

AimsThere is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion‐based VBF device and app was effective for at‐home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms.MethodsA single‐arm 10‐week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2‐week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed‐rank test.ResultsOf 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10‐weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p < 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052).ConclusionsIn this pilot study, there was significant improvement in FI symptom‐specific severity and quality of life using a vaginal, motion‐based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting.

Clinical and functional outcome of surgery for posttraumatic cloacal deformity.

Cloacal deformity is a disabling condition that severely affects a patient's quality of life. Surgery to repair cloacal deformity remains the mainstay of treatment. The aim of this study is to assess the clinical and functional outcome of patients treated for traumatic cloacal deformity by three different techniques. A retrospective multicentre study was carried out using data from women operated on for cloacal deformity between 2015 and 2019. Demographic characteristics, the presence of urinary and/or faecal incontinence and manometric findings were collected. The main outcome measures were represented by St Mark's and Rockwood faecal incontinence quality of life scores. Thirty eight women with a median age of 34years [interquartile range (IQR) 31-39years] were enrolled. Perineoplasty was performed in 23 patients by direct suture of the rectovaginal septum, in five using the X-flap and in 10 by the Singapore flap. Median resting and squeezing pressures increased significantly from 28.15 (IQR 23-32.7)cmH2 O to 45 (IQR 31-60.7) cmH2 O (p=0.0001) and from 47 (IQR 41.2-54.7)cmH2 O to 97.2 (IQR 80-118)cmH2 O (p=0.0001), respectively. Maximum tolerable volume improved from 120 (IQR 90-137.5)ml to 137.5 (IQR 120-150)ml (p=0.002). The St Mark's score decreased from 18 (IQR 14-20) to 4.5 (IQR 2-8) after 20months (p=0001). Sexual activity was confirmed by 16 patients preoperatively and by 27 postoperatively. A diverting stoma was performed in three patients after X-flap perineoplasty and in 14 treated by direct closure. No significant differences were found pre- and postoperatively between the three groups. Regardless of the technique used, surgical repair significantly improves both clinical and functional outcomes irrespective of the presence of a covering stoma.

Long-Term Patient-Reported Quality of Life and Functional Outcomes After Chemoradiation Using Intensity Modulated Radiotherapy for Anal Cancer

Few studies have long-term follow-up assessing patient-reported outcomes (PROs) after intensity-modulated radiation therapy (IMRT)-based chemoradiation (CRT) for squamous cell carcinoma of the anus (SCCA). There is poor agreement between physician-graded toxicity and PROs regarding quality of life (QOL) in patients with SCCA. Therefore, we surveyed SCCA survivors ≥ 2 years out from CRT with validated PRO instruments assessing bowel, bladder, and sexual function.We identified 248 patients with SCCA treated with definitive IMRT-based CRT at a large tertiary cancer center from 2010-2018, who were alive and without recurrence. Patients were asked to complete five PRO instruments: Fecal Incontinence QOL Scale (FIQOL), Low Anterior Resection Syndrome Score (LARS), International Consultation on Incontinence Questionnaire (ICIQ), male and female lower urinary tract symptoms (MLUTS and FLUTS, respectively), International Index of Erectile Function (IIEF), and Female Sexual Function Index (FSFI). FIQOL, LARS, IIEF, and FSFI scores were dichotomized and logistic regression used to identify predictors of QOL scores.One hundred eight (44%) patients completed the PROs. Respondents' median [interquartile range, (IQR)] age was 66 [59-72] years, 80% were female, and 95% were white. Median [IQR] gross tumor volume (GTV) was 45 [27-71] cc; dose to GTV was 50 Gray (Gy), 54 Gy and 58 Gy in 25%, 53%, and 22%, respectively. Median [IQR] time from CRT was 51 [37-84] months. Median [IQR] FIQOL score was 14.3/20 [11.2-16.1]; higher is better. Larger GTV size (OR 0.99; P = 0.03) was associated with lower FIQOL score. Sixty-one (56%) patients met major LARS criteria. There was a trend towards a higher incidence of major LARS with GTV dose ≥ 54 Gy (OR 2.39; P = 0.08). Men had median [IQR] ICIQ MLUTS voiding and incontinence scores of 5/20 [2-6] and 1/24 [1-3], respectively. Women had median [IQR] ICIQ FLUTS voiding and incontinence scores of 1/12 [1-3] and 5/20 [3-8], respectively; higher is worse. Fifty-nine (55%) patients reported being sexually active in the last month. Men had a median [IQR] IIEF score of 14/25 [6-19]; higher is better. Only age (OR 1.17; P = 0.04) was significantly associated with IIEF ≤ 11 (moderate or severe ED). Women had a median [IQR] FSFI score of 20.2/26 [13.6-24.9]; higher is better. Age < 65 was associated with sexual dysfunction, defined as FSFI < 26.55 (OR, 5.5; P = 0.04). Forty (37%) patients disagreed or strongly disagreed that they were prepared for long-term side effects. Seventy (65%) patients agreed or strongly agreed that educational materials would have been helpful.SCCA survivors experience significant long-term bowel and sexual toxicities from modern CRT. Larger tumors and higher RT doses may be associated with worse function. Interventions to reduce toxicities and improve patient education are needed.

Abdominal Oblique Internal and External Muscles Gap Colostomy for Lower Incidence of Parastomal Hernia and Higher Quality of Life: A Retrospective Cohort Study.

Parastomal hernia and fecalincontinence cause severe distress to the rectal cancer patients with stoma after abdominoperineal resection. We attempted a new colostomy technique through the gap between the abdominal oblique internal and external muscles to prevent parastomal hernia and improve quality of life. This cohort study retrospectively examined clinical data from a total of 114 consecutive rectal cancer patients who underwent laparoscopic abdominoperineal resection in our center from March 2016 to March 2018 after propensityscorematching. Group A included 57 patients who underwent colostomy through the gap between the abdominal oblique internal and oblique external muscles, while group B included 57 patients who underwent extraperitoneal colostomy. Patients' quality of life was evaluated using Fecal Incontinence Quality of Life (FIQL) Scale. Group A had a lower incidence of parastomal hernia (0% vs. 15.7%, p = 0.004) and higher quality of life, especially in lifestyle, coping/behavior and embarrassment domains (all p values < 0.05) than group B both during the follow-up period. The incidence of other outcomes did not differ between the groups. Colostomy through the gap between the abdominal oblique internal and oblique external muscle is a new technique showing both safety and effectiveness for preventing parastomal hernia and improving quality of life after laparoscopic abdominoperineal resection.