Consenso Baiona sobre Incontinencia Fecal: Asociación Española de Coloproctología / Baiona's Consensus Statement for Fecal Incontinence. Spanish Association of Coloproctology

La incontinencia fecal (IF) constituye un importante problema sanitario, tanto a nivel individual como para los diferentes sistemas de salud, lo que origina una preocupación generalizada para su resolución o, al menos, disminuir en lo posible los numerosos efectos indeseables que provoca, al margen del elevado gasto que ocasiona. Existen diferentes criterios relacionados con las pruebas diagnósticas a realizar, y lo mismo acontece con relación al tratamiento más adecuado, dentro de las numerosas opciones que han proliferado durante los últimos años, no siempre basadas en una rigurosa evidencia científica. Por dicho motivo, desde la Asociación Española de Coloproctología (AECP) nos propusimos elaborar un Consenso que sirviese de orientación a todos los profesionales sanitarios interesados en el problema, conscientes, no obstante, de que la decisión terapéutica debe tomarse de manera individualizada: características del paciente/experiencia del terapeuta. Para su elaboración optamos por la técnica de grupo nominal. Los niveles de evidencia y los grados de recomendación se establecieron de acuerdo a los criterios del Oxford Centre for Evidence-Based Medicine. Por otra parte, en cada uno de los ítems analizados se añadieron, de forma breve, recomendaciones de los expertos.(AU)

Faecal incontinence (FI) is a major health problem, both for individuals and for health systems. It is obvious that, for all these reasons, there is widespread concern for healing it or, at least, reducing as far as possible its numerous undesirable effects, in addition to the high costs it entails. There are different criteria for the diagnostic tests to be carried out and the same applies to the most appropriate treatment, among the numerous options that have proliferated in recent years, not always based on rigorous scientific evidence. For this reason, the Spanish Association of Coloproctology (AECP) proposed to draw up a Consensus to serve as a guide for all health professionals interested in the problem, aware, however, that the therapeutic decision must be taken on an individual basis: patient characteristics/experience of the care team. For its development it was adopted the Nominal Group Technique methodology. The Levels of Evidence and Grades of Recommendation were established according to the criteria of the Oxford Centre for Evidence-Based Medicine. In addition, expert recommendations were added briefly to each of the items analysed.(AU)

Efficacy of atypical antipsychotics in the treatment of fecal incontinence in children and adolescents: a randomized clinical trial.

OBJECTIVES: Functional retentive overflow incontinence (retentive FI) is the most common cause of fecal soiling in children. Based on the clinical experiences, the treatment of retentive FI in patients with comorbid psychiatric disorders was accelerated when Risperidone was used as treatment for their psychiatric comorbidities; therefore, this study was conducted to evaluate the effect of risperidone in the treatment of retentive FI in children and adolescents. METHODS: In this double-blind, randomized, placebo-controlled trial, 140 patients aged 4-16 years eligible for the study were randomized into two groups, receiving either 0.25-0.5 mg of Risperidone syrup (n = 70) or maltodextrin syrup (placebo group, n = 70) every 12 h daily for 12 weeks. Sociodemographic data, including age, sex, weight, height, BMI, BMI z-score, and socioeconomic status, was recorded, and the number of nocturnal FI, diurnal FI, and painful defecations was measured. RESULTS: 136 participants (69 on Risperidone and 67 on placebo) were included in the study. Mean age of participants in the intervention and placebo groups were 7.2 ± 2.4 years and 8.0 ± 3.1 years, respectively. The mean number of nocturnal FI (Ptrend=0.39) and diurnal FI (Ptrend=0.48) in patients without psychiatric comorbidities, and the number of painful defecations for participants with and without psychiatric comorbidities (P = 0.49, P = 0.47, respectively) were not significantly different between the groups, but a significant effect was observed in diurnal FI after Risperidone treatment in patients with psychiatric comorbidities (P < 0.001). CONCLUSION: Risperidone, when used along with other non-pharmacological interventions, may be helpful in treating FI in pediatric patients with psychiatric comorbidities.

A randomized double-blind trial of clonidine and colesevelam for women with fecal incontinence.

BACKGROUND: Diarrhea and rectal urgency are risk factors for fecal incontinence (FI). The effectiveness of bowel modifiers for improving FI is unclear. METHODS: In this double-blind, parallel-group, randomized trial, women with urge FI were randomly assigned in a 1:1 ratio to a combination of oral clonidine (0.1 mg twice daily) with colesevelam (1875 mg twice daily) or two inert tablets for 4 weeks. The primary outcome was a ≥50% decrease in number of weekly FI episodes. KEY RESULTS: Fifty-six participants were randomly assigned to clonidine-colesevelam (n = 24) or placebo (n = 32); 51 (91%) completed 4 weeks of treatment. At baseline, participants had a mean (SD) of 7.5 (8.2) FI episodes weekly. The primary outcome was met for 13 of 24 participants (54%) treated with clonidine-colesevelam versus 17 of 32 (53%) treated with placebo (p = 0.85). The Bristol stool form score decreased significantly, reflecting more formed stools with clonidine-colesevelam treatment (mean [SD], 4.5 [1.5] to 3.2 [1.5]; p = 0.02) but not with placebo (4.2 [1.9] to 4.1 [1.9]; p = 0.47). The proportion of FI episodes for semiformed stools decreased significantly from a mean (SD) of 76% (8%) to 61% (10%) in the clonidine-colesevelam group (p = 0.007) but not the placebo group (61% [8%] to 67% [8%]; p = 0.76). However, these treatment effects did not differ significantly between groups. Overall, clonidine-colesevelam was well tolerated. CONCLUSIONS AND INFERENCES: Compared with placebo, clonidine-colesevelam did not significantly improve FI despite being associated with more formed stools and fewer FI episodes for semiformed stools.

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

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

Efficacy and safety of probiotics and synbiotics for functional constipation in children: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND & AIM: We aimed to evaluate the efficacy and safety of probiotics and synbiotics in childhood functional constipation. METHODS: PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) were searched up to June 2023. Randomized controlled trials involving children diagnosed with FC with Rome III/IV criteria were included. Treatment success, defecation frequency, stool consistency, painful defecation, fecal incontinence, and adverse events were assessed as outcomes. Odds ratios (ORs) and standard mean difference (SMD) with 95% confidence intervals (CIs) were calculated for dichotomous and continuous variables as appropriate. Cochrane risk-of-bias tool version 2 assessed the risk of bias. RESULTS: Seventeen RCTs with 1504 patients were included. Compared to placebo, probiotics significantly improved defecation frequency (SMD 0.40, 95% CI 0.10 to 0.70, I2 = 0%) and fecal incontinence (OR 0.53, 95% CI 0.29 to 0.96, I2 = 0%). However, it did not significantly improve treatment success, painful defecation, and abdominal pain. Probiotics, as add-on therapy, failed to yield a significant difference in treatment success (OR 0.82, 95% CI 0.15 to 4.48, I2 = 52%), defecation frequency (SMD 0.13, 95% CI -0.13 to 0.39, I2 = 0%), defecation consistency (SMD -0.01, 95% CI -0.40 to 0.38, I2 = 1%), fecal incontinence (OR 0.95, 95% CI 0.48 to 1.90, I2 = 0%), and abdominal pain (OR, 0.60, 95% CI 0.24 to 1.53, I2 = 0%) versus laxatives monotherapy. Synbiotics plus laxatives showed no significant effect on defecation frequency (SMD -0.57; 95% CI -1.29 to 0.14, I2 = 74%) and painful defecation (OR, 3.39; 95% CI 0.74 to 15.55, I2 = 0%) versus laxatives alone. CONCLUSIONS: Current evidence did not advocate using probiotics and synbiotics in treating functional constipation in children. At this time, the effects of strain-specific probiotics, probiotics mixtures, and the optimal doses and treatment durations of the probiotics and synbiotics were unclear. Additional rigorous evidence is required to evaluate and establish the effectiveness and safety of probiotics and synbiotics for childhood functional constipation. PROSPERO ID: CRD42020195869.

Effects of testosterone treatment on anal sphincter damage repair in ovariectomized rats.

BACKGROUND: Fecal incontinence (FI) generally occurs with anal sphincter damage caused by vaginal delivery in women, obvious FI can develop in the postmenopausal stage. This pelvic floor dysfunction has no rational medical therapeutic options. We investigated the effect of testosterone treatment on the anal sphincter structure, serum thiol/disulfide levels, uterine tissue, and body composition in female rats in an experimental menopause-FI model. METHODS: The animal experiments were performed between September and November 2020 at Experimental Animal Application and Research Center, Afyon Kocatepe University, Afyonkarahisar, Turkey. Thirty-two female rats were divided into four groups: sham, saline, 10 mg/kg testosterone undecanoate, 100 mg/kg testosterone undecanoate. Except for the sham group, all the other groups underwent ovariectomy (OVE) to create a menopause model. Two weeks after this procedure, the FI model was created under general anesthesia in all rat groups. At the end of the experiment, the rats were placed under general anesthesia, weighed, and euthanized after recording the data. The anal sphincter region and uterine tissue samples were collected for histopathological examinations, and blood samples were collected for total testosterone and thiol/disulfide homeostasis analyses. RESULTS: An increase in anal sphincter muscles and connective tissue thickness was observed in the testosterone-administered groups (p = 0.001). No difference was detected between the groups in the total thiol, native thiol, and disulfide balance (p = 0.087, p = 0.604, p = 0.092). The testosterone-treated groups did not have severe uterine epithelial degradation, hyperemia, or increased endometrial thickness (p = 0.186, p = 0.222, p = 0.630). The body weight of all rats increased (p < 0.05), but the omental weight did not increase (p = 0.061). DISCUSSION: Testosterone treatment increased the anal sphincter muscle and connective tissue thickness without causing any oxidative stress and did not result in a pathological change in the uterine tissue and body fat composition.

A short- and long-term follow-up study of intersphincteric NASHA Dx implants for fecal incontinence.

BACKGROUND: The bulking agent NASHA Dx injected into the submucosal layer is effective in the treatment of fecal incontinence (FI) at short-and medium-term follow-up but efficacy after injection in the intersphincteric location is unknown. The aim of this study was to determine the short- and long-term efficacy and safety of NASHA Dx injected into the intersphincteric location for FI. METHODS: Patients were recruited from referrals to our Department for treatment of FI in November 2008-January 2010. Eligible patients were injected with 8 ml of NASHA Dx. Patients with a subtotal treatment effect were retreated after 2-4 weeks. The change in number of fecal incontinence episodes, the proportion of responders defined as at least 50% decrease in number of FI episodes and side effects were the main outcome measures. RESULTS: Sixteen patients, 15 women and 1 man with a median age of 68, 5 (range 44-80) years and a median CCFIS of 15 (range 10-19) were included in the study. The median number of incontinence episodes decreased from 21.5 (range 8-61) at baseline to 10 (range 0-30) at 6 months (p = 0.003) and 6 (range 0-44) at 12 months (p = 0.05). The median number of incontinence episodes in the 11 patients completing the 10-year follow-up was 26.5 (range 0-68). The percentage of responders at 12 months and 10 years were 56% and 27%, respectively. Mild to moderate pain at the injection site was described by 69%. There was one case of mild infection, successfully treated with antibiotics and one implant had to be removed due to dislocation. CONCLUSIONS: NASHA Dx as an intersphincteric implant improves incontinence symptoms in the short term with moderate side effects and can be used alone or as an adjunct to other treatment modalities. Long-term efficacy was observed in 27%.

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.

Preclinical testing of an anal bulking agent coated with a zwitterionic polymer in a fecal incontinence rat model.

Fecal incontinence is a disabling condition in which the passage of fecal material cannot be controlled. Although the condition is not life-threatening, it can seriously reduce the quality of life of a patient by isolating them from others. Though various surgical treatments are available for moderate to severe symptoms, a bulking agent is a minimally invasive technique that has attracted attention because of its safety and simple treatment process. However, the biocompatibility of bulking agent materials remains a central issue, with their durability questioned because immune responses and/or the circulatory system may remove the bulking agent in vivo. This study investigated a bulking agent composed of polydimethylsiloxane and hyaluronic acid as a microfiller and carrier gel, respectively. To improve the injectability of the bulking agent, the filler size was tuned using a suspension-based fabrication technique. To evade immune responses, the filler surface was treated with a zwitterionic polymer that simultaneously functionalized and stabilized the material interfaces. The resulting bulking agent exhibited good injectability and biocompatibility in vitro, with 58% lower protein adsorption and no cytotoxicity, leading to an improved bulking effect in a preclinical rat model compared with a bulking agent without surface treatment. These results illustrate the promising potential of bulking agents as a therapy for fecal incontinence with reduced foreign body reactions and long-lasting efficacy.

Oncologic and Functional Outcomes of Pelvic Perineal Reconstruction by Perineal Colostomy and Malone Procedure After Abdominoperineal Resection.

BACKGROUND: Abdominoperineal resection is the standard curative surgical technique for locally advanced adenocarcinoma of the lower rectum and squamous cell carcinoma of the anal canal after chemoradiotherapy. However, it requires a definitive abdominal colostomy that modifies the body appearance. OBJECTIVE: The study aim was to evaluate the combination of abdominoperineal resection with perineal colostomy reconstruction and Malone antegrade continence enema. DESIGN: This was a retrospective study. SETTINGS: The study was conducted at the Toulouse Hospital Digestive Surgery Department. PATIENTS: All of the patients with advanced adenocarcinoma or squamous cell carcinoma who underwent abdominoperineal resection with perineal colostomy reconstruction and Malone antegrade continence enema (n = 80) between December 1999 and December 2016 were included. MAIN OUTCOME MEASURES: The main outcome was the 5-year overall survival rate. RESULTS: The 5-year overall survival was 74.89% (95% CI, 62.91%-83.50%), and the median recurrence-free survival was 107.6 months (95% CI, 65.1-198.1 mo). The median follow-up was 91.0 months (95% CI, 70.4-116.6 mo). R0 resection was obtained in 64 patients (80.0%). The median Cleveland Clinic Incontinence Score (to assess the functional outcomes) was 9.0 (interquartile range, 1.0-18.0), and it was lower in patients with advanced adenocarcinoma than with squamous cell carcinoma (7.0 (interquartile range, 2.0-18.0) vs 11.0 (interquartile range, 1.0-17.0); p = 0.01). Eleven patients (13.8%) reported perineal stains during the night, and 19 patients (23.8%) needed drugs to reduce colon motility. The rate of severe complications (Clavien-Dindo >II) was 11.7% (n = 9). Definitive colostomy was performed in 15 patients (18.8%). LIMITATIONS: This retrospective study included a small number of patients from a single center. Moreover, the functional outcome was tested with self-report questionnaires (risk of response bias). CONCLUSIONS: This study suggests that abdominoperineal resection associated with perineal reconstruction by perineal colostomy and Malone antegrade continence enema is safe and may improve patient quality of life. See Video Abstract at http://links.lww.com/DCR/B629. RESULTADOS ONCOLGICOS Y FUNCIONALES DE LA RECONSTRUCCIN PLVIPERINEAL MEDIANTE COLOSTOMA PERINEAL Y PROCEDIMIENTO DE MALONE DESPUS DE LA RESECCIN ABDOMINOPERINEAL: ANTECEDENTES:La resección abdominoperineal es la técnica quirúrgica curativa estándar para el tratamiento del adenocarcinoma localmente avanzado del recto inferior y el carcinoma a células escamosas del canal anal, después de radio-quimioterapia. Sin embargo, requiere una colostomía abdominal definitiva que modifica la apariencia corporal.OBJETIVO:El propósito del presente estudio fue el evaluar la combinación de la resección abdominoperineal con la confección de una colostomía perineal asociada a enemas de continencia anterógrada según Malone.DISEÑO:Estudio retrospectivo.AJUSTES:Servicio de Cirugía Digestiva del Hospital de Toulouse, Francia.PACIENTES:Se incluyeron todos los pacientes con adenocarcinoma avanzado o carcinoma de células escamosas que se sometieron a resección abdominoperineal con la confección de una colostomía perineal asociada a enemas de continencia anterógrada según Malone (n = 80) entre diciembre de 1999 y diciembre de 2016.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue la tasa de sobrevida global a 5 años.RESULTADOS:La sobrevida global a 5 años fue de 74,89% (IC del 95%, 62,91 a 83,50) y la mediana de supervivencia libre de recurrencia fue de 107,6 meses (IC del 95%, 65,1 a 198,1). La mediana de seguimiento fue de 91,0 meses (IC del 95%, 70,4-116,6). La resección R0 se obtuvo en 64 pacientes (80,0%). La mediana de puntuación de la escala de incontinencia de la Cleveland Clinic (para evaluar los resultados funcionales) fue de 9,0 [1,0; 18,0], y fue menor en pacientes con adenocarcinoma avanzado que con carcinoma de células escamosas (7,0 [2,0; 18,0] versus 11,0 [1,0; 17,0]; p = 0,01). Once pacientes (13,8%) refirieron manchado perineal nocurno y 19 pacientes (23,8%) necesitaron fármacos para reducir la motilidad del colon. La tasa de complicaciones graves (Clavien-Dindo > II) fue del 11,7% (n = 9). Se realizó colostomía definitiva en 15 (18,8%) pacientes.LIMITACIONES:Este estudio retrospectivo incluyó un pequeño número de pacientes y de un solo centro. Además, el resultado funcional se probó con cuestionarios de autoinforme (riesgo de sesgo de respuesta).CONCLUSIONES:Este estudio sugiere que la resección abdominoperineal asociada con la confección de una colostomía perineal asociada a enemas de continencia anterógrada según Malone es segura y puede mejorar la calidad de vida de los pacientes. Consulte Video Resumen en http://links.lww.com/DCR/B629.

Importancia de algunos aspectos técnicos del procedimiento de estimulación percutánea del nervio tibial posterior en pacientes con incontinencia fecal / Importance of some technical aspects of the procedure of percutaneous posterior tibial nerve stimulation in patients with fecal incontinence

Introducción: Los resultados de la estimulación percutánea del nervio tibial posterior (PTNS) en el tratamiento de la incontinencia fecal (IF) parecen discretos. El objetivo del estudio es valorar la relación de algunos aspectos técnicos con la respuesta clínica: localización del nervio, respuesta distal (motora o sensitiva) y acomodación. Métodos: Estudio prospectivo de pacientes con IF sometidos a terapia de PTNS. La repuesta clínica se valoró mediante la escala de Wexner, diario defecatorio y manometría anorrectal. Resultados: Se estudiaron 32 pacientes. La intensidad de localización (cercanía al nervio) no se correlacionó con cambios clínicos ni manométricos. La respuesta motora se relacionó con un descenso en la escala de Wexner [12,12 (± 5,39) a 7,71 (± 4,57) p < 0,005], el número de episodios de incontinencia pasiva [8,78 (± 9,64) a 4,11 (± 7,11) p = 0,025], el número total de episodios de incontinencia [16,11 (± 16,03) a 7,78 (± 11,34) p = 0,009] y el número de días con ensuciamiento fecal [6,89 (± 5,53) a 2,56 (± 4,13) p = 0,002] y con un aumento de la longitud del conducto anal manométrico en reposo [4,55 (± 0,596) a 4,95 (± 0,213) p = 0,004]. El incremento de estimulación (acomodación) se correlacionó de forma inversa con la disminución en la escala de Wexner (r = -0,677 p < 0,005) y el número de días con ensuciamiento (r = -0,650 p = 0,022). Conclusiones: La respuesta motora durante la PTNS parece relacionarse con una mejor respuesta clínica. El fenómeno de acomodación podría asociarse con peores resultados. La cercanía del electrodo al nervio no parece tener trascendencia, siempre que se consiga una buena respuesta distal. (AU)

Introduction: The 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. Methods: Prospective study of patients with FI undergoing PTNS therapy. The clinical response was assessed using the Wexner scale, defecation diary and anorectal manometry. Results: 32 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 < 0.005], the number of episodes of passive incontinence [8.78 (± 9.64) to 4.11 (± 7.11) p = 0.025], the total number of incontinence episodes [16.11 (± 16.03) to 7.78 (± 11.34) p = 0.009] and the number of days with faecal soiling [6.89 (± 5.53) to 2.56 (± 4.13) p = 0.002] and with an increase in the length of the manometric anal canal at rest [4.55 (± 0.596) to 4.95 (± 0.213) p = 0.004]. The increase in stimulation (accommodation) was inversely correlated with the decrease in the Wexner scale (r = -0.677 p < 0.005) and the number of days with soiling (r = -0.650 p = 0.022). Conclusions: The 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. (AU)

Effect of darifenacin on fecal incontinence in women with double incontinence.

INTRODUCTION AND HYPOTHESIS: To evaluate change in fecal incontinence symptom severity after 8 weeks of darifenacin therapy in patients with double incontinence-urgency urinary incontinence (UUI) and fecal incontinence. Important secondary outcomes included fecal incontinence symptom distress and impact on quality of life, fecal incontinence episodes, global impression of improvement and overactive bladder symptom distress and impact. METHODS: Prospective open-label cohort study of women presenting primarily with UUI, diagnosed with double incontinence and electing antimuscarinic therapy for UUI. Women ≥ 18 years with moderate or greater bothersome UUI and fecal incontinence of liquid/solid stool with St. Marks (Vaizey) score ≥ 12 were included. Subjects were treated with darifenacin 15 mg daily for 8 weeks. The primary outcome was change in fecal incontinence symptom severity using the St. Marks (Vaizey) score after 8 weeks. Sample size was based on the minimally important difference of the St. Marks, -5, and standard deviation, ± 8.5; 30 subjects provided 80% power and type I error of 0.05, including a 15% attrition rate. RESULTS: Thirty-two women were consented with mean baseline St. Marks (Vaizey) score of 18.0 ± 3.0. Mean age was 66.5 ± 10.3 years. Twenty-eight subjects (29/32, 87.5%) completed assessments. St. Marks (Vaizey) score significantly improved from 18.0 to 11.0 [mean difference - 7.0, 95% confidence interval (CI): -8.7, -5.3], and 19 subjects (19/32,67.9%) met the minimally important difference. Statistically significant improvements were also noted in fecal incontinence frequency, quality of life, and overactive bladder symptom bother and quality of life (all p < 0.01). CONCLUSIONS: Darifenacin can be considered a highly effective early intervention in women suffering from double incontinence. CLINICAL TRIAL REGISTRATION: Bladder Antimuscarinic Medication and Accidental Bowel Leakage (BAMA), https://clinicaltrials.gov/ct2/show/NCT03543566 , NCT03543566.

[Symptoms of diabetic gastroenteropathy in patients with diabetes].

Abdominal pain, nausea, vomiting, diarrhoea, constipation, and faecal incontinence are common symptoms of diabetic gastroenteropathy and often have a major impact on quality of life. The symptoms are usually caused by widespread dysfunction of the gastrointestinal tract. Hence, diagnosis requires panenteric assessment. The general principles of management are glycaemic control, diet, prokinetics, laxatives, and in selected cases, gastric electrical stimulation, which is summarised in this review.

Assessing the benefit of reoperations in patients who suffer from fecal incontinence after repair of their anorectal malformation.

BACKGROUND AND AIM: Patients with a previously repaired anorectal malformation (ARM) can suffer from complications which lead to incontinence. Reoperation can improve the anatomic result, but its impact on functional outcomes is unclear. METHODS: We performed a retrospective cohort study of patients with a previously repaired ARM who underwent redo PSARP at our Center and compared results at initial assessment and 12 months after redo. RESULTS: One hundred fifty-three patients underwent a redo PSARP for anoplasty mislocation (n=93, 61%), stricture (n=55, 36%), remnant of the original fistula (n=28, 18%), or rectal prolapse (n=11, 7%). Post-redo complications included stricture (n=33, 22%) and dehiscence (n=5, 3%). At 1-year post-redo, 75/153 (49%) are on laxatives only, of whom 57 (76%) are continent of stool. Of the remaining 78 (51%) patients, 61 (78%) are clean (≤1 accident per week) on enemas. Interestingly, 16/79 (20%) of patients with expected poor continence potential were continent of stool on laxatives. Overall, 118/153 (77%) are clean after their redo. Quality of life (76.7 vs. 83.8, p=0.05) and Baylor continence (29.2 vs. 17.7, p=<0.0001) scores improved. CONCLUSION: Patients with fecal incontinence after an ARM repair can, with a reoperation, have their anatomy corrected which can restore continence for many, and improve their quality of life. LEVEL OF EVIDENCE: IV. TYPE OF STUDY: Retrospective cohort study.

Subtype classification of functional constipation in children: polyethylene glycol versus lactulose.

BACKGROUND: This study aimed to evaluate the usefulness, from a therapeutic perspective, of classifying the subtypes of functional childhood constipation using a colon transit time (CTT) test. METHODS: A total of 190 children were enrolled in this study, which was based on data collected from a defecation diary, a CTT test, and medical records. RESULTS: Polyethylene glycol (PEG) 4000 was prescribed in 51.1% (N = 47/92) of normal transit type constipation cases (NT) and 91.8% (N = 90/98) of abnormal transit type constipation cases (P < 0.001). In terms of the subtype of CTT test, PEG 4000 was prescribed in 51.1% (N = 47/92) of NT cases, 96.2% (N = 25/26) of outlet obstruction type cases (OT), and 90.3% (N = 65/72) of slow transit type cases (ST) (P < 0.001). Polyethylene glycol 4000 was administered in 97.2% (N = 35/36) of the fecal incontinence group and 66.2% (N = 102/154) of the non-fecal incontinence group (P < 0.001). In the non-fecal incontinence group, PEG 4000 was prescribed in 47.3% (N = 40/84) of NT cases, 94.4% (N = 17/18) of OT cases, and 86.5% (N = 45/52) of ST cases (P < 0.001). In the fecal incontinence group, PEG 4000 was prescribed in 87.5% (N = 7/8) of NT cases, 100% (N = 8/8) of OT cases, and 100% (N = 20/20) of ST cases (P = 0.165). CONCLUSIONS: Subtype classification of functional constipation based on the CTT test provides important information for the initial choice of drugs in children.

Effect of oestrogen therapy on faecal incontinence in postmenopausal women: a systematic review.

INTRODUCTION AND HYPOTHESIS: Faecal incontinence (FI) is prevalent in postmenopausal women. Oestrogen receptors have been identified in the anal sphincter and have been implicated in the pathogenesis and potential treatment. We sought to evaluate the literature regarding the impact of local and systemic oestrogen therapy on FI in postmenopausal women. METHODS: A systematic review of all studies in postmenopausal women was performed to establish how oestrogen therapy affects FI. Eight articles were deemed eligible for inclusion following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Their quality was assessed using the Cochrane risk-of-bias tool (RoB-2) and Newcastle-Ottawa quality assessment scale. RESULTS: One randomised controlled trial (RCT), two cohort studies, one observational and four cross-sectional studies were identified. The RCT showed an improvement in FI with anal oestrogen (p = 0.002), but this improvement was also observed in the placebo arm (p = 0.013) and no difference was seen between these groups. A prospective observational study demonstrated significant improvement with an oestrogen patch (p = 0.004), but had no control group. Conversely, a large prospective cohort study demonstrated an increased hazard ratio of FI with current (1.32; 95% CI, 1.20-1.45) and previous oestrogen use (1.26; 95% CI, 1.18-1.34) compared with non-users. CONCLUSION: All studies had a high risk of bias and had conflicting views on the effects of oestrogen on FI in postmenopausal women. This review has identified the need for further research in this area by highlighting the paucity of good research for evidence-based practice. We believe that a further RCT of local oestrogen is mandated to draw a valid conclusion.

Neuroestimulación/neuromodulación sacra en incontinencia fecal y/o urinaria / Sacral neurostimulation/neuromodulation in fecal and/or urinary incontinence

CONTEXTO: La incontinencia urinaria (IU), o trastorno del vaciado vesical, se define como la incapacidad de mantener un control de la micción. Los trastornos del vaciado vesical se dividen en cuatro tipos generalmente, éstos son: IU de urgencia (generalmente asociado al síndrome de vejiga hiperactiva); IU de esfuerzo (pérdida de orina asociado al ejercicio, al toser o estornudar); IU mixta (combinación de las dos previas) y finalmente la IU por rebosamiento o retención urinaria no obstructiva. Las estimaciones de prevalencia de estas afectaciones varían debido a las diferencias en las definiciones, pero se ha reportado hasta un 55% en mujeres adultas. La IU de urgencia y la de esfuerzo son los tipos más frecuentes de IU crónica, con una prevalencia del 31% en mujeres mayores de 75 años y de 24 a 45% en mujeres mayores de 30 años, respectivamente. Tanto los hombres como las mujeres se ven afectados, siendo las mujeres más propensas a experimentar la incontinencia. TECNOLOGÍA: La neuromodulación sacra consiste en un generador de pulsos implantable que suministra impulsos eléctricos controlados. El dispositivo utilizado para conseguir la estimulación cuenta con un generador el cual está conectado a cables que conectan con los nervios sacros, generalmente a nivel de la raíz de S3. Dos componentes externos del dispositivo ayudan a controlar la estimulación eléctrica: um magneto de control es accionado por el paciente para prender y apagar el dispositivo y una consola programadora puede ser utilizada por el médico para ajustar los pulsos del generador. Los pacientes deben poder operar el dispositivo y llevar un diario de evacuaciones. OBJETIVO: El objetivo del presente informe es evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de neuroestimulación/ neuromodulador em incontinencia fecal y/o urinaria. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas, en buscadores genéricos de internet, y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS), evaluaciones económicas, guías de práctica clínica (GPC) y políticas de cobertura de diferentes sistemas de salud. RESULTADOS: Se incluyeron cinco RS, tres estudios prospectivos no controlados, cinco GPC, una evaluación económica, y 26 informes de políticas de cobertura neuromodulación sacra en incontinencia fecal y/o urinaria. CONCLUSIÓN: Evidencia de moderada calidad sugiere que la terapia con neuromodulación sacra, en comparación con otras alternativas terapéuticas, podría reducir el número de eventos de incontinencia urinaria y mejorar la calidad de vida de adultos que han fallado a otras líneas de tratamiento conservador, estos resultados fueron observados en el corto y mediano plazo. Evidencia de moderada calidad sugiere que la terapia con neuromodulación sacra, en comparación con la estimulación del tibial posterior, podría reducir el número de eventos de incontinencia fecal en adultos que han fallado a otras líneas de tratamiento conservador, estos resultados fueron observados en el corto y mediano plazo. Evidencia de muy baja calidad no permite evaluar la eficacia y seguridad de neuromodulación sacra en pacientes pediátricos con incontinencia fecal. Evidencia de muy baja calidad, proveniente de dos series de casos, no permiten sacar conclusiones acerca de la eficacia y seguridad de la neuroestimulación sacra en pacientes adultos com coexistencia de incontinencia fecal y urinaria. Las guías de práctica clínica que han sido relevadas sobre incontinencia fecal o incontinência urinaria contemplan a la neuromodulación sacra como una alternativa terapéutica en tercera línea de tratamiento. Las políticas de cobertura que han sido relevadas en América Latina no mencionan la cobertura de esta tecnología. Los financiadores públicos de Francia, Australia, Estados Unidos, Reino Unido y los privados de Estados Unidos que han sido relevados brindan cobertura de esta tecnología para las dos indicaciones evaluadas. No se hallaron estudios económicos realizados en Argentina que permitan conocer la costo-efectividad y/o el impacto presupuestario de esta tecnología.

Acupuncture for fecal incontinence: Protocol for a systematic review and data mining.

BACKGROUND: Fecal incontinence is a socially and emotionally destructive condition that has a negative impact on personal image, self-confidence, and quality of life. Acupuncture is commonly used to treat chronic conditions, including fecal incontinence. However, no relevant systematic review or meta-analysis has been designed to evaluate the effects of acupuncture on fecal incontinence. METHODS: We will identify relevant randomized controlled trials (RCTs) from the Cochrane Library, Medline, Embase, PubMed, Springer, Web of Science, China National Knowledge Infrastructure, VIP Chinese Science and Technology Journals Database, Wanfang database, and clinical trial registration center from their inception to February 28, 2019. The primary outcome measures will be clinical effective rate, functional outcomes, and quality of life. Data that meets the inclusion criteria will be extracted and analyzed using RevMan V.5.3 software. Two reviewers will evaluate the studies using the Cochrane Collaboration risk of bias tool. Publication bias will be assessed by funnel plots, Egger test, and Begg test using the Stata software. Acupoints characteristics will be analyzed by Traditional Chinese Medicine inheritance support system. RESULTS: This study will analyze the clinical effective rate, functional outcomes, quality of life, daily average number of fecal incontinence, and effective prescriptions of acupuncture for patients with fecal incontinence. CONCLUSION: Our findings will provide evidence for the effectiveness and potential treatment prescriptions of acupuncture for patients with fecal incontinence. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019119680.

Topical Oxymetazoline for Fecal Incontinence in Patients with Spinal Cord Injury: A Double-Blind Randomized Controlled Crossover Study.

BACKGROUND: Topical α-agonists contract the internal anal sphincter muscle; therefore, they may serve as treatment for fecal incontinence. OBJECTIVES: The aim of this study was to investigate the effect of the α-agonist oxymetazoline 1.0% on fecal incontinence in patients with spinal cord injury. DESIGN: This was a double-blind, crossover study. Before randomization, all patients underwent a 1-day, open-label anal manometry and pharmacokinetic study. SETTINGS: The study was conducted at the Department of Internal Medicine, Semmelweis University, Hungary. PATIENTS: Nineteen patients were enrolled into a randomized double-blind, placebo-controlled clinical trial with 2 arms: placebo for 4 weeks followed by oxymetazoline for 4 weeks, or vice versa, with an interval 2-week washout period, in a crossover trial design. Treatment order was randomly assigned, and fecal incontinence was captured with daily diaries. MAIN OUTCOME MEASURES: The primary outcome measured was the number of fecal incontinence episodes in the 8 and 12 hours after drug administration. RESULTS: Resting anal pressure increased in response to oxymetzoline (25.2%). The change in the mean fecal incontinence episodes per month (12 hours post drug application) favored oxymetazoline over placebo: 26.3 (SD ±28.4) versus 36 (SD ±39.8) (p = 0.021). When only nongas episodes were included, the mean number of episodes decreased from 10.1 (+4.3) to 6.3 (±2.1) fecal incontinence episodes per month (p = 0.022). No difference was observed in adverse events between treatment and placebo periods. All pharmacokinetic samples were below the detection limit. LIMITATIONS: The study was limited by the small number of participants. CONCLUSIONS: In this study, oxymetazoline gel presented a clear clinical beneficial effect accompanied by a favorable safety and tolerability profile. Results of the pharmacokinetic analysis indicate that the clinical benefit was mainly due to a local effect of oxymetazoline. Future studies are planned to investigate higher doses of oxymetazoline for this indication. See Video Abstract at http://links.lww.com/DCR/A797.