Treatment Of Fecal Incontinence Research Articles

The effect of biofeedback pelvic floor training with ACTICORE1 on fecal incontinence A prospective multicentric cohort pilot study

IntroductionFecal incontinence refers to the inability to pass stool in a localized and timely manner resulting in the involuntary loss of intestinal contents such as air, intestinal mucus or stool. The prevalence of fecal incontinence in the general population is approximately 2–21%. Women are more frequently affected than men. Physiotherapeutically guided pelvic floor training, otherwise known as Kegel exercise, is the mainstay of treatment for fecal incontinence. The objective of this study was to evaluate the feasibility and potential benefits of a new biofeedback training, which uses a non-insertable pelvic floor sensor with digital interface, called ACTICORE1. MethodsFrom January 2020 to April 2021, we conducted a prospective non-randomized multicentric clinical pilot study at the Alexianer St. Hedwig Hospital Berlin (Germany), private clinic Strack (Germany) and the University Hospital Magdeburg (Germany). Patients with fecal incontinence, defined as a Wexner score >2, were recruited and asked to either perform biofeedback training with ACTICORE1 (6 min daily for 16 weeks) or daily Kegel exercise (Physiotherapeutic guidance weekly for the first 6 weeks; biweekly for the remaining 10 weeks). The primary outcome was severity of fecal incontinence after 16 weeks of training assessed using the Wexner score. Secondary outcomes were severity of fecal incontinence after 12 weeks and patients’ quality of life assessed using the EQ-5D-3L questionnaire after 16 weeks of training. The two-one-sided t-tests (TOST) procedure was used to determine if training with ACTICORE1 has equivalent or noninferior efficacies compared to Kegel exercise. ResultsA total of 40 individuals were included. Dropout occurred in 4 cases. The final sample included 19 patients who performed the ACTICORE1 training (ACTICORE-group) and 17 patients who performed guideline-based physiotherapy (PHYSIO-group). Univariate analysis of biometric parameters showed no statistically significant differences. Individuals in the ACTICORE-group were younger (M=46,6 (SD=18,9) years vs. M=57,1 (SD=17,3) years, p=0.093). In terms of endpoint evaluation, a non-inferiority of ACTICORE1 compared to the therapy standard (Kegel exercise) was detected. Both groups showed a statistically significant intraindividual improvement in fecal incontinence as measured by Wexner scoring after 16 weeks. The TOST detected a non-inferiority of ACTICORE1 training (98% confidence interval with equivalence bounds 5 for low and high; Results: 1.36, upper 6.75). ConclusionPelvic floor training with ACTICORE1 may enable sufficient pelvic floor training as a digital health application. The study at hand revealed a non-inferiority of ACTICORE1 training compared to Kegel exercise.

Biofeedback pelvic floor muscle training and posterior tibial nerve electrostimulation for treatment of faecal incontinence: monotherapy versus combined therapy: a prospective randomized trial

BackgroundFaecal incontinence is a common anorectal medical trouble among adult population. The aim was to compare the efficacy of biofeedback pelvic floor muscle training versus posterior tibial nerve electrical stimulation versus combination of both of them in treatment of patients with faecal incontinence. The study included 71 randomly selected patients with faecal incontinence. Eleven patients had one or more exclusion criteria were excluded from the study. Sixty patients were included in the trial. They were randomly assigned to receive biofeedback pelvic floor muscle training (biofeedback group), posterior tibial nerve electrostimulation (posterior tibial nerve electrostimulation group) or combined therapy (combined group). Primary outcome measure was Wexner Faecal Continence scale. Secondary outcome measures were maximal squeezing anal pressure, maximal voluntary anal contraction time and patient global assessment of effect of faecal incontinence on quality of life. The outcome measures were recorded twice, before treatment and after treatment by six weeks.ResultsNo statistical significant differences were present between the three groups regarding different baseline clinical characteristics. Significant differences were present between the initial and follow-up assessment of the outcome measures within the three groups. However, there were significant differences between the three groups regarding the outcome measures within follow-up assessment. There were 14 patients (70%) showed successful outcome in the combined group versus 11 patients (55%) in the biofeedback group and 6 patients (30%) in the posterior tibial nerve electrostimulation group.ConclusionsCombination therapy of biofeedback pelvic floor muscle training and posterior tibial nerve electrostimulation in the treatment of patient with faecal incontinence is quantitatively better than biofeedback pelvic floor muscle training therapy alone and superior to posterior tibial nerve electrostimulation therapy alone, as well as biofeedback pelvic floor muscle training therapy is superior to posterior tibial nerve electrostimulation therapy. This combination could be recommended as an effective treatment for faecal incontinence. It increases the anal sphincter squeezing pressure with improvement in the patients’ quality of life.Trial registration: Pan African Clinical Trials Registry, PACTR202008862941254. Registered 24 August 2020—Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12291.

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

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.

Результати реконструктивних операцій при вродженій аноколоректальній патології в дітей

Fecal incontinence (FI) in children is a serious medical and social problem. FI leads to severe limitations in a child’s development and social adaptation. Pediatric surgeons mainly deal with the mechanical type of FI that occurs after surgical correction of anorectal malformations (ARM) or Hirschsprung's disease (HD). Violation of defecation control is observed in 53-89% of patients who underwent surgery for ARM and HD. Purpose - to study the causes and effectiveness of the proposed complex treatment of FI in children operated on for HD and ARM. Materials and methods. Clinical examination and treatment of 92 children with congenital pathology of the distal colon and anus (55 (59.78%) patients with HG and 37 (40.22%) with ARM) was carried out at the Pediatric Surgery Clinic of Ivano-Frankivsk National Medical University. Among the surveyed children were 64 boys and 28 girls (ratio - 2.29:1). In terms of age, newborns and children of the first year of life predominated among those who underwent primary surgery - 57 (61.95%) children. FI of varying severity was detected in 48 (52.17%) patients operated on for HD and ARM at different terms after surgical correction - from 6 months to 3 years. The types, causes, and severity of FI in each child were studied. In addition to conventional clinical and instrumental studies, patients underwent anoscopy and rectoscopy, transanal ultrasound, anorectal manometry. The severity of AI was assessed on a S.D. Wexner score. Results. FI occurred in 34 (70.8%) children after HD correction and in 14 (29.2%) patients after ARM surgery. True FI was found in 33 (68.75%) children. Pseudoincontinence was detected in 15 (31.25%) patients it was more common in patients operated on for HD. For conservative treatment of patients with FI a Bowel Management Program was implemented. In 24 (50.0%) patients treated according to this program, the control of defecation was significantly improved, the incontinence severity index was significantly reduced according to the Wexner score. In true AI due to severe anal sphincter damage, we performed minimally invasive surgical correction of postoperative insufficiency or congenital defect of the internal sphincter of the anus using a volume-forming implant in 14 (29.17%) children. Immediate and long-term results of the operation were good, which was reflected in improved control of defecation, a significant increase of basal pressure and a decrease of the incontinence severity index. Conclusions. Tactics of the FI treatment depends on the cause and severity. The implementation of the Bowel Management Program can significantly improve the control of defecation and improve the quality of life of patients. In case of insufficiency of the internal anal sphincter, minimally invasive correction by anal submucosal implantation of a volume-forming gel is effective. The research was carried out in accordance with the principles of the Helsinki declaration. The study protocol was approved by the Local ethics committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors. Key words: fecal incontinence, anorectal malformations, Hirschsprung's disease, children.

Testosterone Sustained Release Microspheres for the Treatment of Fecal Incontinence

The objective of this study was to develop a testosterone sustained release formulation for the treatment of fecal incontinence. To suppress the initial burst release of testosterone, which can lead to systemic toxicity, we incorporated a washing step using an aminoalkyl methacrylate copolymer E solution or propylene glycol solution into a typical o/w emulsion method to prepare polylactic-co-glycolic acid microspheres. We used this method to develop a polylactic-co-glycolic acid microsphere formulation that shows sustained release of testosterone for up to one month. Not only did this formulation show a sustained release profile after administration into the intersphincteric groove in minipigs, it also increased both the anal pressure and mass of the external anal sphincter, while keeping systemic testosterone exposure low. Thus, this formulation successfully affected both the internal and external anal sphincters with a sufficient safety profile, deeming it a promising candidate treatment strategy for fecal incontinence.

Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration.

IntroductionThe goal of this project was to create an up‐to‐date joint European clinical practice guideline for the diagnosis and treatment of faecal incontinence (FI), using the best available evidence. These guidelines are intended to help guide all medical professionals treating adult patients with FI (e.g., general practitioners, surgeons, gastroenterologists, other healthcare workers) and any patients who are interested in information regarding the diagnosis and management of FI.MethodsThese guidelines have been created in cooperation with members from the United European Gastroenterology (UEG), European Society of Coloproctology (ESCP), European Society of Neurogastroenterology and Motility (ESNM) and the European Society for Primary Care Gastroenterology (ESPCG). These members made up the guideline development group (GDG). Additionally, a patient advisory board (PAB) was created to reflect and comment on the draft guidelines from a patient perspective. Relevant review questions were established by the GDG along with a set of outcomes most important for decision making. A systematic literature search was performed using these review questions and outcomes as a framework. For each predefined review question, the study or studies with the highest level of study design were included. If evidence of a higher‐level study design was available, no lower level of evidence was sought or included. Data from the studies were extracted by two reviewers for each predefined important outcome within each review question. Where possible, forest plots were created. After summarising the results for each review question, a systematic quality assessment using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was performed. For each review question, we assessed the quality of evidence for every predetermined important outcome. After evidence review and quality assessment were completed, recommendations could be formulated. The wording used for each recommendation was dependent on the level of quality of evidence. Lower levels of evidence resulted in weaker recommendations and higher levels of evidence resulted in stronger recommendations. Recommendations were discussed within the GDG to reach consensus.ResultsThese guidelines contain 45 recommendations on the classification, diagnosis and management of FI in adult patients.ConclusionThese multidisciplinary European guidelines provide an up‐to‐date comprehensive evidence‐based framework with recommendations on the diagnosis and management of adult patients who suffer from FI.

Pelvic floor behavioral treatment for fecal incontinence and constipation in quiescent inflammatory bowel disease

Background and aim Refractory bowel symptoms in quiescent inflammatory bowel disease (IBD) are common but evidence for effective management is limited. We aimed to determine whether behavioral treatment, including pelvic floor muscle training, decreases the severity of functional bowel symptoms in patients with quiescent IBD. Secondary aims were to evaluate the treatment effect on quality of life, psychological well-being and pelvic floor muscle function. Methods This prospective study included IBD patients in remission with persistent symptoms of fecal incontinence or constipation who received up to six sessions of behavioral treatment at monthly intervals. The primary outcome was patient-rated symptom improvement on a 7-point Likert scale (1 = substantially worse, 7 = substantially better). Secondary outcomes included validated symptom scores, quality-of-life, psychological measures, and transperineal ultrasound assessment of pelvic floor muscle activity. Results Thirty-four patients (median age 38 years; 24 females; 18 ulcerative colitis, 13 Crohn’s disease, 3 ileo-anal pouch) were included. Twenty-one of the 29 (72%) patients who completed treatment, or 21 of all 34 (62%) patients, reported moderate or substantial improvement (patient rating of 6 or 7). Symptom scores (p < .001), IBD-specific quality of life (p = .008) and illness perception scores (p = .003) significantly improved. General quality of life, and anxiety and depression scores, did not change significantly. Transperineal ultrasound pelvic floor measures did not correlate with patient-rating of symptom improvement. Conclusion Significant symptomatic improvement occurred in a majority of patients with quiescent IBD. Behavioral treatment should be considered for patients with quiescent IBD and ongoing functional bowel symptoms of fecal incontinence, fecal urgency, or constipation.

Report from 'ESCP 2021 Virtual': the 16th Scientific and Annual Conference of the European Society of Coloproctology, 22-24 September 2021.

Report from 'ESCP 2021 Virtual': the 16th Scientific and Annual Conference of the European Society of Coloproctology, 22-24 September 2021.

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.

Sacral neuromodulation for faecal incontinence – 10 years experience and long-term outcomes of a specialized centre

Sacral neuromodulation/sacral nerve stimulation (SNM/SNS) has become the most successful method for treatment of faecal incontinence (FI) in the last 10 years. The high efficiency of SNM is based on the electrical stimulation of the external anal sphincter and moreover the mechanism of action of SNS can be explained by the modulation of somatovisceral reflexes and perceptions of afferent information. Therefore the mechanism of action is more complex in contrast to other methods of treatment. In the Czech Republic, the SNM was implemented for the first time in 2010 with the financial support of the IGA grant of the Ministry of Health of the Czech Republic. Since 2018, two specialized centres for the treatment of FI using the SNM method have been established in the Czech Republic. In the years 20102020, 35 patients were indicated for SNM. The ratio of women to men was 34:1. The mean age at implantation was 62 years (range 4675). Most patients were in the 6th and 7th decade. Two diagnostic procedures were performed in all patients, percutaneous evaluation of the S2S4 sacral nerves, implantation of the Medtronic 3889 28cm stimulation tined lead electrode and its connection to an external stimulator and subsequent subchronic stimulation for 24 weeks. The criteria for permanent neurostimulator implantation were a minimum 50% reduction in the number of FI episodes per week or a 50% reduction in incontinence score. Patients were then implanted with a Medtronic InterStim II 3058 permanent neurostimulator. A permanent neurostimulator was implanted in 33 of 35 patients (94%). No patient died. The complication rate was 11.4%. In 2 patients it was an infectious complication. In one patient malposition of the stimulator occurred after falling down and in one patient we observed lead breakage with subsequent malfunction of the stimulator after falling down. All complications were successfully resolved by reoperation. The longterm effect of SNM was evaluated in the group of the first 15 implanted patients from 20102011. Of these, 9 patients were available, in whom a new neurostimulator was reimplanted due to loss of battery power in 20182020. The mean length of follow-up was 112 months (99124). The mean number of FI episodes per week was 1.9 (013) after neurostimulator implantation compared to 13.6 (325) before implantation. The Cleveland Clinic Incontinence Score (CCIS) was 8.3 (316) after neurostimulator implantation compared to CCIS 18.8 (1520) before implantation. Both FI episode counts and CCIS scores were significantly lower (p.

New techniques in the repair of anal sphincter between success and failure

Abstract Background Fecal incontinence is a frequent and debilitating condition that may result from a multitude of different causes. It is defined as the uncontrolled passage of faeces or gas over at least 1 month’s duration, in an individual of at least 4 years of age, who had previously achieved control. Aim of Work to evaluate the outcome of overlap anal sphincter repair as regard the anal continence and postoperative complications. Patients and Methods this is a prospective clinical trial was conducted on thirty (30) patients presented to Ain-Shams University hospitals with anal sphincter injury that were operated upon by a modified overlap repair done by the same surgical team. Endoanal ultrasonography was done and Wexner continence score was estimated for all cases preoperatively and postoperatively. All patients sharing in the study were fully informed about the procedure they had with a written informed consent. Results In this study the mean preoperative Wexner score was 12.9 and the mean postoperative Wexner was 4.8; this reduction was found to be significant (p value=0.001). Also endoanal ultrasound showed that tear size significantly reduced among the studied cases(p value=0.001). Conclusion from this study that overlapping sphincter repair is an effective method in the treatment of faecal incontinence in patients with repairable sphincter defects. However, long term follow up is required to confirm its efficacy.

Treatment of Fecal Incontinence With a Rechargeable Sacral Neuromodulation System: Efficacy, Clinical Outcome, and Ease of Use—Six-Month Follow-Up

Sacral neuromodulation is an effective treatment for fecal incontinence (FI) after conservative treatments have failed. A new rechargeable sacral neuromodulation system (r-SNM) includes a rechargeable implantable neurostimulator (INS). No data is available of the use of this technology in patients with fecal incontinence. Fifteen patients with FI were implanted with the Axonics rechargeable SNM system in a single-stage implant procedure and prospectively followed. Primary outcome was fecal incontinence episodes at four weeks and six months measured with stools diary. Success was defined as at least 50% improvement of fecal incontinence episodes. Additionally, quality of life and ease of use were evaluated. At four weeks, 13 participants (87%) were test responders based on ≥50% reduction in FI episodes as documented on their bowel diary. Weekly FI episodes decreased from a median (25%-75% range) of 8 (5.8-20.3) at baseline to a median of 1.5 (0.4-4.5) at four weeks (p=0.001), and 1.5 (0-2.6) at six months (p=0.001), corresponding to 75% and 79% reduction in weekly FI episodes. Of the 13 subjects having ≥50% reduction in FI episodes at four weeks, 12 (PP=92%) were therapy responders at six months. There were no unanticipated device or procedure-related adverse events. Mean time to recharge the system was 37 ± 3min once or twice per week. All patients were moderately or very satisfied with the system and its effect. The r-SNM system provides safe and effective therapy in patients with FI at six months.

Pelvic Floor Biofeedback for the Treatment of Urinary Incontinence and Fecal Incontinence

Pelvic floor muscle dysfunction and symptoms of incontinence may affect any gender and age. Incontinence is embarrassing and socially limiting for patients and is not the result of normal aging. This health issue can successfully be treated with surface electromyography (sEMG) biofeedback when this modality is used by a knowledgeable and skilled provider. In combination with sEMG, behavioral intervention regarding fluid intake, normalized toileting patterns, and education on muscle function empower patients to overcome their symptoms. This article describes two patient cases, one with stress incontinence and fecal incontinence, the other with urge incontinence.

End-to-end anal Sphincter Repair in Treatment of Post-traumatic Fecal Incontinence

AbstractThe present report describes the end-to-end technique of anal sphincter repair in a 36-year-old female patient with post-vaginal delivery fecal incontinence (FI). The patient had a history of two vaginal deliveries and the symptoms of FI were observed after the second delivery. On assessment of the severity of FI using the Wexner incontinence score, the patient had a score of 12. Endoanal ultrasonography revealed an anterior defect of the external anal sphincter extending from 11 to 3 o'clock. The patient had no previous anal surgery and did not have any medical comorbidities.The operation time was 45 minutes. No intraoperative complications were recorded. At 12 months of follow-up, the patient showed significant improvement in the continence state, with her Wexner score dropping to 4. No postoperative complications were recorded. We can conclude that end-to-end anal sphincter repair is a technically feasible operation that confers satisfactory improvement in the continence state without imposing much tension on the site of sphincter repair.

The Efficacy of Biofeedback Therapy for the Treatment of Fecal Incontinence After Soave Procedure in Children for Hirschsprung's Disease.

Introduction: Hirschsprung's disease is a common digestive tract malformation in children, and the Soave procedure is one of the classic surgical methods for Hirschsprung's disease (HD). Fecal incontinence is one of the most common postoperative complications that can cause significant distress to the patients and their family, the incidence of which is 20% in a recent series. Biofeedback therapy (BFT) can be an effective treatment for managing anorectal disorders, but there has been little report of the efficacy of BFT for the treatment of fecal incontinence after the Soave procedure, and the main objective of this study is to evaluate it.Methods: We retrospectively analyzed postoperative fecal incontinence in 46 children who received the Soave procedure for HD and who received BFT at our institution from March 2016 to February 2020, which included 38 males and 8 females (mean age 8.1 years, from 3.7 to 14 years). Anal sphincter contraction training was performed using BFT for 10 days per session in the hospital, one time each day, and 20 min each time. BFT was performed by employing visual and verbal feedback techniques using the biofeedback instrument. Long-term functional outcomes were objectively assessed using the Rintala Bowel Function Score (RBFS), and the patients were scored according to the sum total as excellent (18–20 points, 0 case), good (11–16 points, 0 case), fair (9–11 points, 9 cases), or poor (6–9 points, 37 cases). Defecation questionnaires and anorectal manometry were completed pretreatment and after three, six, or nine sessions, and primary outcome measures of anorectal manometry were anal maximal contraction pressure (AMCP), anal longest contraction time (ALCT), rectal rest pressure (RRP), and anal rest pressure (ARP).Results: Followed up from 6 months to 4 years, the symptoms of fecal incontinence disappeared completely in 39 (84.78%) patients. Among them, 14 (30.43%) had complete disappearance of symptoms after 3 sessions of treatment, 25 (54.34%) patients had improved symptoms after 6 sessions of treatment, symptoms completely disappeared after 6 sessions of treatment, and 7 (15.22%) cases still suffered fecal incontinence mildly. The AMCP after three and six sessions in the poor group was significantly increased compared with that before treatment [(85.87 ± 31.75) mmHg vs. (135.33 ± 37.69) mmHg vs. (128.41 ± 33.45) mmHg, P < 0.05]. The ALCT and ARP showed the same trend, while the RRP after three and six sessions were not significant (P > 0.05). The mean (±SD) score of the RBFS increased from 9 to 17.40 ± 0.84 in the fair group, while it increased from 7.22 ± 0.76 to 16.58 ± 1.66 in the poor group after six sessions (P < 0.05).Conclusion: Biofeedback therapy is a safe and effective treatment of fecal incontinence after the Soave procedure of children for Hirschsprung's disease. It is beneficial to design the individualized treatment programs for the children with varying degrees of fecal incontinence.

The Efficacy of Biofeedback Treatment in Patients with Fecal Incontinence.

The initial treatment for fecal incontinence (FI) includes supportive treatment and medical treatment. If the initial treatment fails, biofeedback therapy (BFT) is recommended. However, there are limited and conflicting results in the literature supporting the beneficial effect of BFT for FI. The aim of the study is to analyze the efficacy of BFT in 126 patients who have FI due to several causes. The data of 126 patients (88 females (69.8%) and 38 males (30.2%)) were collected retrospectively. Colonoscopy, anorectal manometry (ARM), and 3D-Endoanal ultrasonography (EAUS) were performed for all patients before applying BFT. In addition, all patients received toilet training instruction and training in Kegel and other pelvic floor strengthening exercises from an experienced nurse, before BFT. The median age of participants was 54 years (range 18-75 years). While 80 patients (63.5%) had clinical and manometric benefit from BFT, 46 patients (36.5%) did not respond to BFT. According to the EAUS and ARM findings, BFT was beneficial in patients who had partial external sphincter failure, and was unsuccessful in patients who had both internal and external sphincter failure, both internal and external sphincter tears, and external sphincter tear rates of more than 25%. After BFT, significant increases in squeeze pressures were observed, with this increase being higher in the positive-response group. The results suggest that BFT is effective in the treatment of FI for specific patient populations.

In utero myelomeningocele repair and incidence of lower urinary tract surgery. Results of a prospective study

The purpose of this study was to determine the incidence of lower urinary tract surgery in patients with myelomeningocele (MMC) operated in utero as well as in the subgroup of patients with a minimum age of 5 years. We use a previously published protocol to categorize bladder patterns and propose the treatment: high risk pattern-anticholinergics and clean intermittent catheterization (CIC); incontinent and normal patterns-clinical surveillance and underactivity pattern- CIC. Non-response to clinical treatment with maintenance of detrusor pressure higher than 40 cmH20 with worsening of hydronephrosis or recurrent urinary infection were imperative indications for surgery and urinary incontinence due to sphincter deficiency and leakage pressure below 40 cmH20 in patients aged 5 years and older were possible indications too. We identified the prevalence of urinary tract surgery and concomitant treatment of constipation and refractory fecal incontinence by convenience, the technique performed and surgery outcomes. A total of 122 patients are part of the prospective protocol. The first UE was performed in 119 patients (median age of 4 months). The categorization of the bladder pattern was high risk in 52.1%, incontinent in 25.2%, hypocontractile 4.2% and normal in 18.5%. Current follow-up was 29.9 months (1-99 months). Surgery was performed on 10 patients (8.4%): 3 vesicostomies, 2 surgeries to treat vesicoureteral reflux, 6 bladder augmentations, 3 ACE and a sling surgery. Considering only patients older than 5 years, we identified 65 patients and seven surgeries performed (10.8%). Most bladder reconstruction studies are case series of single institutions or cooperative services, most of which are retrospective. The prospective clinical interpretation and imaging and urodynamic exams over time allowed us prospectively to define the risk of surgery in patients with myelomeningocele operated in utero. It must be considered that the response to the initial urological treatment and even the failure that leads to the need for surgery have to be evaluated in a context of follow-up time. For this reason we have studied separately patients over 5 years-old and also the group considered to be at greatest risk for surgery, the high-risk group of the categorization already described. We found an incidence of 10.8% of surgeries in patients over 5 years-old and 12.9% for the high-risk group. This information may be useful to educate parents when stating urological treatment.

Importance of some technical aspects of the procedure of percutaneous posterior tibial nerve stimulation in patients with fecal incontinence

IntroductionThe results of percutaneous posterior tibial nerve stimulation (PTNS) in the treatment of fecal incontinence (IF) are modest. The aim of the study is to assess the relationship of some technical aspects with the clinical response: location of the nerve, distal response (motor or sensory) and accommodation. MethodsProspective study of patients with FI undergoing PTNS therapy. The clinical response was assessed using the Wexner scale, defecation diary and anorectal manometry. Results32 patients were studied. The intensity of localization (proximity to the nerve) was not correlated with clinical or manometric changes. Motor response was associated with a decrease on the Wexner scale [12.12 (±5.39) to 7.71 (±4.57) P < .005], the number of episodes of passive incontinence [8.78 (±9.64) to 4.11 (±7.11) P = .025], the total number of incontinence episodes [16.11 (±16.03) to 7.78 (±11.34) P = .009] and the number of days with fecal soiling [6.89 (±5.53) to 2.56 (±4.13) P = .002] and with an increase in the length of the manometric anal canal at rest [4.55 (±0.596) to 4.95 (±0.213) P = .004]. The increase in stimulation (accommodation) was inversely correlated with the decrease in the Wexner scale (r = −0.677 P < .005) and the number of days with soiling (r = −0.650 P = .022). ConclusionsThe motor response during PTNS seems to be related to a better clinical response. The accommodation phenomenon could be associated with worse results. The proximity of the electrode to the nerve does not seem to be important as long as a good distal response is achieved.

Injection of aluminum potassium sulfate and tannic acid in the treatment of fecal incontinence: a single-center observational study.

Perianal injection of bulking agents is an attractive treatment option for patients with mild to moderate fecal incontinence (FI). Various bulking agents have been used for injection therapy, but the optimal injection materials and methods are yet to be standardized. This study aimed to evaluate the effects of injection therapy using aluminum potassium sulfate and tannic acid (ALTA) in the management of FI. This study included consecutive patients who underwent ALTA injection therapy for FI at our institution. The procedure was performed with the patient in the jackknife position, under caudal epidural anesthesia. The procedure consisted of a 4-step injection to the 3 main cushions and a multipoint injection to the remaining submucosa of the anal canal. Seventy-seven patients (mean age, 76 years) were enrolled in the study. The mean Cleveland Clinic incontinence score of 11.9 ± 4.1 at baseline significantly improved to 7.3 ± 5.2 at 3 months following treatment. The mean maximal resting pressure also increased significantly 3 months after the intervention. Postoperative complications were observed in 3 patients (3.9%), and all events were mild. The mean duration of postoperative follow-up was 17.5 months. The cumulative recurrence-free rate at 3 years was 72.4%. ALTA injection for FI is safe, easy to perform, and provides reasonable mid-term outcomes. Moreover, concomitant anorectal diseases that may be contraindicated by other injectable bulking agents could be treated simultaneously. Therefore, ALTA injection is a promising alternative in the absence of other injectable agents.

Comparative effectiveness of biofeedback and injectable bulking agents for treatment of fecal incontinence: Design and methods

Fecal incontinence (FI), the involuntary passage of stool, is common and can markedly impair the quality of life. Among patients who fail initial options (pads or protective devices, bowel modifying agents, and pelvic floor exercises), the options are pelvic floor biofeedback (BIO), perianal injection with bulking agents (INJ), and sacral nerve electrical stimulation (SNS), which have not been subjected to head-to-head comparisons. This study will compare the safety and efficacy of BIO and INJ for managing FI. The impact of these approaches on quality-of-life and psychological distress, cost effectiveness, and predictors of response to therapy will also be evaluated. Six centers in the United States will enroll approximately 285 patients with moderate to severe FI. Patients who have 4 or more FI episodes over 2 weeks proceed to a 4-week trial of enhanced medical management (EMM) (ie, education, bowel management, and pelvic floor exercises). Thereafter, 194 non-responders as defined by a less than 75% reduction in the frequency of FI will be randomized to BIO or INJ. Three months later, the efficacy, safety, and cost of therapy will be assessed; non-responders will be invited to choose to add the other treatment or SNS for the remainder of the study. Early EMM responders will be re-evaluated 3 months later and non-responders randomized to BIO or INJ. Standardized, and where appropriate validated approaches will be used for study procedures, which will be performed by trained personnel. Prospectively collected data on care costs and resource utilization will be used for cost effectiveness analyses.