Sacral neuromodulation for constipation and fecal incontinence in children and adolescents - study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique.

BACKGROUND: A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to investigate effects of SNM in pediatric constipation in a prospective parallel-group trial. METHODS: A monocentric, randomized, unblinded, parallel-group trial is conducted. SNM is conducted in the invasive variant and in an innovative, external approach with adhesive electrodes (enteral neuromodulation, ENM). We include patients with constipation according to the ROME IV criteria and refractory to conventional options. Patients with functional constipation and Hirschsprung's disease are able to participate. Participants are allocated in a 1:1 ratio to either SNM or ENM group. Clinical data and quality of life is evaluated in regular check-ups. Neuromodulation is applied continuously for 3 months (end point of the study) with follow-up-points at 6 and 12 months. Findings are analyzed statistically considering a 5% significance level (p ≤ 0.05). Outcome variables are defined as change in (1) episodes of abdominal pain, (2) episodes of FI, (3) defecation frequency, (4) stool consistency. Improvement of proprioception, influence on urinary incontinence, quality of life and safety of treatment are assessed as secondary outcome variables. We expect a relevant improvement in both study groups. DISCUSSION: This is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM). TRIAL REGISTRATION: The study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01/14/2021).

Baiona's Consensus Statement for Fecal Incontinence. Spanish Association of Coloproctology.

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.

Optimizing the Utility of Anorectal Manometry for Diagnosis and Therapy: A Roundtable Review and Recommendations.

BACKGROUND & AIMS: Anorectal manometry (ARM) is a comprehensive diagnostic tool for evaluating patients with constipation, fecal incontinence, or anorectal pain; however, it is not widely utilized for reasons that remain unclear. The aim of this roundtable discussion was to critically examine the current clinical practices of ARM and biofeedback therapy by physicians and surgeons in both academic and community settings. METHODS: Leaders in medical and surgical gastroenterology and physical therapy with interest in anorectal disorders were surveyed regarding practice patterns and utilization of these technologies. Subsequently, a roundtable was held to discuss survey results, explore current diagnostic and therapeutic challenges with these technologies, review the literature, and generate consensus-based recommendations. RESULTS: ARM identifies key pathophysiological abnormalities such as dyssynergic defecation, anal sphincter weakness, or rectal sensory dysfunction, and is a critical component of biofeedback therapy, an evidence-based treatment for patients with dyssynergic defecation and fecal incontinence. Additionally, ARM has the potential to enhance health-related quality of life and reduce healthcare costs. However, it has significant barriers that include a lack of education and training of healthcare providers regarding the utility and availability of ARM and biofeedback procedures, as well as challenges with condition-specific testing protocols and interpretation. Additional barriers include understanding when to perform, where to refer, and how to use these technologies, and confusion over billing practices. CONCLUSIONS: Overcoming these challenges with appropriate education, training, collaborative research, and evidence-based guidelines for ARM testing and biofeedback therapy could significantly enhance patient care of anorectal disorders.

Electrical stimulation of the dorsal clitoral nerve in the treatment of idiopathic defecatory urgency. A pilot study.

PURPOSE: To investigate the effect of dorsal clitoral nerve stimulation (DCNS) on bothersome urgency to defecate with or without fecal incontinence and the patient-reported discomfort or adverse effect with the method. METHODS: For dorsal clitoral nerve stimulation, a battery powered, handheld stimulator was used, set to a pulse width of 200 µs and a frequency of 20 Hz. One electrode was placed at the preputium of the clitoris and acted as cathode while an anode electrode was placed on the belly. Prior to stimulation the patients were asked to complete a bowel habit diary throughout 14 consecutive days before and during stimulation. RESULTS: Fourteen out of the 16 patients included completed the study. A decrease in the number of episodes (per day) with strong urgency declined in eight patients but increased in four cases during the stimulation period. An increase in episodes with moderate or mild urgency was observed in 11 and 6 cases, respectively, and a decrease in defecation without the feeling of urgency or passive incontinence decreased in two thirds of the patients. Two patients discontinued the study prematurely, on due to worsening in symptoms and one due to pelvic pain. CONCLUSION: Although the results may be promising, much still must be learned about the method including mode and duration of stimulation, better electrodes and more patient friendly equipment together with the development of better questionnaires to assess the patient burden of urgency.

Role of 3D high resolution anorectal manometry compared to conventional technique in management of constipation and fecal incontinence in children.

BACKGROUND: Anorectal manometry is a valuable tool for objective assessment of motility motor and sensory function of the anorectum. The aim of this study was to investigate role of water-perfused (WP) three dimensional high-resolution anorectal manometry (3D-HRARM) compared to WP conventional manometry (CM) in the management of chronic idiopathic constipation (CIC) and faecal incontinence (FI) in children. METHODS: This was a retrospective review of 122 consecutive children, who had WP 8-channel CM or 24 channel 3D-HRARM and endosonography under ketamine anaesthesia from September 2012 to February 2019. All patients had a validated symptom severity score questionnaire ranging from 0 (best) to 65 (worst). Mann-Whitney-U test and Spearman rank test were used and p<0.05 was considered significant. RESULTS: Subjects were divided according to investigation: CM group (n = 75) and 3D-HRAM (n = 47), who were otherwise comparable. Median anal resting pressure was 50 mmHg and rectoanal inhibitory reflex (RAIR) threshold volume was 10mls across the entire cohort. There were no significant differences in resting pressure or RAIR threshold when using conventional or 3D-HRARM. Rectal capacity was significantly higher in the CM group (p = 0.002). Rectal capacity and internal anal sphincter (IAS) thickness positively correlated with symptom severity, duration and patient age. 3D-HRARM provided a more detailed depiction of the anorectal pressure profile. Botulinum toxin was injected into the external anal sphincter (EAS) muscle (n = 75, 61%) and an anterograde colonic enema (ACE) stoma was needed subsequently in 19 (16%) to treat recurrent constipation and soiling symptoms. Rectal biopsy was done in 43(35%) patients, if RAIR was absent or inconclusive. CONCLUSION: CM and 3D-HRARM are comparable in terms of resting pressure and RAIR threshold. 3D-HRAM is safe and provides detailed functional morphology of anal sphincters and it is useful to understand underlying pathophysiology of constipation and faecal incontinence in children and plan further treatment. LEVEL OF EVIDENCE: Level I.

[Chinese expert consensus on clinical diagnosis and treatment of fecal incontinence (2022 edition)].

Fecal incontinence is one of the common diseases in the field of colorectal and anal surgery. Its etiology is complex, the treatment response is suboptimal, and there are controversies in clinical care. There is no consensus on the clinical practice of fecal incontinence in China currently. Launched by Anorectal Branch of Chinese Medical Doctor Association, Expert Committee on Anorectal Disease of Anorectal Branch of Chinese Medical Doctor Association, and Clinical Guidelines Committee of Anorectal Branch of Chinese Medical Doctor Association, and organized by the editorial board of Chinese Journal of Gastrointestinal Surgery, Chinese experts on this field were convened to write the Chinese expert consensus on clinical practice of fecal incontinence based on relevant references. After rounds of discussion, the final consensus combines the latest evidence and experts' clinical experience. This expert group suggested that a comprehensive assessment of fecal incontinence should be conducted before treatment, including medical history, relevant scales, physical examination and special examinations. Special examinations include anorectal endoscopy, anorectal manometry, transrectal ultrasound, magnetic resonance, rectal sensation and compliance, balloon ejection test, pelvic floor electromyography, defecography, colonoscopy and pudendal nerve terminal motor latency. Treatment methods include life style modification, medication, surgery, traditional Chinese medicine and other treatments. This consensus aims to standardize the algorithm of fecal incontinence management and improve therapeutic efficacy.

[Fecal incontinence - symptoms are guiding therapy]. / Stuhlinkontinenz ­ vom Symptom zur Therapie.

Fecal incontinence (FI) is an escalating medical problem. Due to increasing life expectancy FI becomes more evident, especially in the geriatric population. The prevalence varies from 4 % in the adult population reaching > 50 % in the octogenerians, yet most probably associated with a significant based error due to underreporting. Diagnosis is depending primarily upon history taking and gathered information from the patient and caregivers. Additional technical diagnostic procedures are of secondary importance. In most cases no single cause for FI can be identified, mostly multifactorial disorders contribute to a progressive loss of anorectal continence. The mainstay in therapeutic approaches to control symptoms comprise changes in lifestyle patterns, physiotherapy and medical therapy, but depend on the patient's compliance. Invasive or even surgical treatments are circumstantial, although sacral neuromodulation has proofed to be a successful treatment modality during the past decades. Ultimately a permanent stoma may lead to symptom control and result in an increased quality of life.

Fecobionics Evaluation of Biofeedback Therapy in Patients With Fecal Incontinence.

INTRODUCTION: Biofeedback therapy (BFT) is a well-known treatment for functional anorectal disorders. The effect of BFT was monitored in fecal incontinence (FI) patients with the Fecobionics test and with the conventional technologies, anorectal manometry (ARM) and balloon expulsion test (BET). METHODS: Studies were performed in 12 patients before and after 8 weeks of biofeedback training. The Fecal Incontinence Severity Index (FISI) score was obtained. Anal resting and squeeze pressures were measured before the bag was distended in the rectum until urge to defecate. Pressure recordings were made during Fecobionics evacuation. RESULTS: BFT resulted in 24% reduction in FISI scores (P < 0.01). Seven patients were characterized as responders. Anal pressures, the urge-to-defecate volume, and defecatory parameters did not change significantly during BFT. For ARM-BET, the maximum anal squeeze pressure, the urge-to-defecate volume, and the expulsion time were lower after BFT compared with those before BFT (P < 0.05). For Fecobionics, the change in urge volume (r = 0.74, P < 0.05) and the change in defecation index (r = 0.79, P < 0.01) were associated with the change in FISI score. None of the ARM-BET parameters were associated with the change in FISI score. It was studied whether any pre-BFT data could predict treatment success. The Fecobionics expulsion duration and the defecation index predicted the outcome (P < 0.05). The defecation index had a sensitivity of 100% and a specificity of 72%. None of the ARM-BET parameters predicted the outcome (all P > 0.2). DISCUSSION: Fecobionics was used as a tool to monitor the effect of BFT and proved better than conventional technologies for monitoring and predicting the outcome in the FISI score.

Is sacral nerve modulation reprogramming effective after permanent implantation for faecal incontinence?

AIM: Sacral nerve modulation (SNM) is recommended as a first-line surgical therapy for patients with faecal incontinence (FI). During patient follow-up, it is recommended that stimulation settings be reprogrammed to optimize patient outcomes. The aim of the present study was to evaluate the efficacy of stimulator reprogramming in patients with an implanted SNM device to treat FI. METHOD: The data from patients who received a permanent SNM implant in a single centre from January 2008 to December 2019 were retrospectively analysed. Symptoms that occurred after implantation, the stimulator settings of the SNM device and changes made at each follow-up visit were noted. The efficacy of reprogramming was determined by assessing patient satisfaction. RESULTS: Of the 117 patients (male/female 4/113; mean age 59.5 ± 11.8 years) with a SNM implant for FI, 84 (72%) had at least one symptom requiring reprogramming of the stimulator, most often during the first year after implantation (p = 0.05). The most frequently reported symptoms were loss of efficacy (68.5%; p = 1 × 10-3 ) and pain (20.5%; p = 1 × 10-3 ). Reprogramming was effective 53% of the time when treating loss of efficacy and 76% of the time when treating pain. When the stimulation parameters were reprogrammed at least four consecutive times to correct a symptom, the reprogramming was less effective in treating the symptom (p = 0.02). CONCLUSION: Regular follow-up of patients with SNM device implants associated with reprogramming of stimulation parameters to improve the treatment of reported symptoms would optimize the efficacy of SNM.

The Efficacy of Biofeedback Treatment in Patients with Fecal Incontinence.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: The results suggest that BFT is effective in the treatment of FI for specific patient populations.

A multicenter study of anorectal pressures and rectal sensation measured with portable manometry in healthy women and men.

BACKGROUND: The equipment and methods for performing anorectal manometry and biofeedback therapy are different and not standardized. Normal values are influenced by age and sex. Our aims were to generate reference values, examine effects of gender and age, and compare anorectal pressures measured with diagnostic and biofeedback catheters and a portable manometry system. METHODS: In this multicenter study, anorectal pressures at rest, during squeeze, and evacuation were measured with diagnostic and biofeedback catheters using Mcompass™ portable device in healthy subjects. Balloon expulsion time and rectal sensation were evaluated. The effects of age and gender were assessed. RESULTS: The final dataset comprised 108 (74 women) of 124 participants with normal rectal balloon expulsion time (less than 60 s). During squeeze, anal resting pressure increased by approximately twofold in women and threefold in men. During evacuation, anal pressure exceeded rectal pressure in 87 participants (diagnostic catheter). The specific rectoanal pressures (e.g., resting pressure) were significantly correlated and not different between diagnostic and biofeedback catheters. With the diagnostic catheter, the anal squeeze pressure and rectal pressure during evacuation were greater in men than women (p ≤ 0.02). Among women, women aged 50 years and older had lower anal resting pressure; rectal pressure and the rectoanal gradient during evacuation were greater in older than younger women (p ≤ 0.01). CONCLUSIONS: Anal and rectal pressures measured with diagnostic and biofeedback manometry catheters were correlated and not significantly different. Pressures were influenced by age and sex, providing reference values in men and women.

New options for managing fecal incontinence in women.

Fecal incontinence often is underreported and can be associated with both social embarrassment and isolation. As patients often do not proactively discuss their symptoms, healthcare providers should screen for this distressing condition. The cause of fecal incontinence often is multifactorial, so no single therapy can guarantee perfect, risk-free outcomes. This article reviews the limited therapies for managing fecal incontinence, including a minimally invasive vaginal control device that may offer hope for managing fecal incontinence in women.

Development and validation of the ICF-Incontinence Assessment Form (ICF-IAF) to identify problems and resources for planning and evaluation of interventions using the Classification of Functioning, Disability and Health of the World Health Organization: Preliminary study.

AIMS: Current level-A recommended questionnaires that provide a valid assessment of urinary incontinence (UI) and/or faecal incontinence (FI), but do not cover all aspects of the burden of the disease in the sense of the bio-psycho-social model of the World Health Organization's International Classification of Functioning, Disability and Health (ICF). Therefore, an ICF oriented questionnaire for patients with UI and/or FI to assess treatment barriers (problems) as well as positive influencing factors (resources), the "ICF-Incontinence Assessment Form" will be developed. The aim of this preliminary study was (a) to identify problems and resources of UI and/or FI in current level-A recommended questionnaires and (b) to evaluate problems and resources of patients with UI and/or FI from the perspective of experienced physiotherapists. METHODS: (a) Current level-A recommended questionnaires for UI and/or FI were analyzed. Questions were linked to the ICF categories. (b) A 3-round Delphi technique survey among 262 physiotherapists from five German-speaking countries was used to evaluate patients' problems and resources relevant to physiotherapy. RESULTS: (a) A total of 27 identified questionnaires were linked to 110 ICF categories. No positive influencing factors could be identified. (b) After Delphi-round 3, 110 categories of problems and 71 resources were identified. CONCLUSION: Since there is a lack of resource items in the present validated questionnaires, there is a need for a short, practical questionnaire to assess and monitor both, problems and resources of patients with UI and/or FI.

A systematic review of non-invasive modalities used to identify women with anal incontinence symptoms after childbirth.

INTRODUCTION AND HYPOTHESIS: Anal incontinence following childbirth is prevalent and has a significant impact upon quality of life (QoL). Currently, there is no standard assessment for women after childbirth to identify these symptoms. This systematic review aimed to identify non-invasive modalities used to identify women with anal incontinence following childbirth and assess response and reporting rates of anal incontinence for these modalities. METHODS: Ovid Medline, Allied and Complementary Medicine Database (AMED), Cumulative Index of Nursing and Allied Health Literature (CINAHL), Cochrane Collaboration, EMBASE and Web of Science databases were searched for studies using non-invasive modalities published from January 1966 to May 2018 to identify women with anal incontinence following childbirth. Study data including type of modality, response rates and reported prevalence of anal incontinence were extracted and critically appraised. RESULTS: One hundred and nine studies were included from 1602 screened articles. Three types of non-invasive modalities were identified: validated questionnaires/symptom scales (n = 36 studies using 15 different instruments), non-validated questionnaires (n = 50 studies) and patient interviews (n = 23 studies). Mean response rates were 92% up to 6 weeks after childbirth. Non-personalised assessment modalities (validated and non-validated questionnaires) were associated with reporting of higher rates of anal incontinence compared with patient interview at all periods of follow-up after childbirth, which was statistically significant between 6 weeks and 1 year after childbirth (p < 0.05). CONCLUSIONS: This systematic review confirms that questionnaires can be used effectively after childbirth to identify women with anal incontinence. Given the methodological limitations associated with non-validated questionnaires, assessing all women following childbirth for pelvic-floor symptomatology, including anal incontinence, using validated questionnaires should be considered.

Efficacy and mechanism of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence: study protocol for a randomised controlled trial.

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

Diagnosis and Management of Fecal Incontinence.

PURPOSE OF REVIEW: The purpose of this review is to highlight current and newer therapeutic approaches to treat fecal incontinence in patients who do not respond to conservative measures. RECENT FINDINGS: Neurostimulation techniques, injection of bulking agents, and radiofrequency energy delivery to the anal canal have been proposed and tested for fecal incontinence over the last decade. Sacral stimulation is both effective and durable and is now the most popular of the invasive techniques whereas percutaneous tibial stimulation, radiofrequency energy, and bulking agents are either less effective or their evaluation has been handicapped by suboptimal study designs. The precise indications for the new vaginal control device and anal plugs remain to be established. The magnetic anal sphincter is disappointing. Stem cell therapy is a potentially exciting approach, which is in its infancy. There continues to be an unmet need for innovative approaches to patients with fecal incontinence who do not respond to conservative measures. The efficacy of current and future therapies should be assessed using criteria more stringent than has been used in the past to provide a more realistic assessment of meaningful efficacy.

Anorectal Function and Quality of Life in Patients With Early Stage Rectal Cancer Treated With Chemoradiation and Local Excision.

BACKGROUND: Little is known about anorectal function and quality of life after chemoradiation followed by local excision, which is an alternative to total mesorectal excision for selected patients with early rectal cancer. OBJECTIVE: The purpose of this study was to prospectively assess anorectal function and health-related quality of life of patients with T2N0 rectal cancer who were treated with an alternative approach. DESIGN: This was a prospective, phase II trial. SETTINGS: The study was multicentric (American College of Surgeons Oncology Group trial Z6041). INTERVENTIONS: Patients with stage cT2N0 rectal adenocarcinomas were treated with an oxaliplatin/capecitabine-based chemoradiation regimen followed by local excision. MAIN OUTCOME MEASURES: Anorectal function and quality of life were assessed at enrollment and 1 year postoperatively with the Fecal Incontinence Severity Index, Fecal Incontinence Quality of Life scale, and Functional Assessment of Cancer Therapy-Colorectal Questionnaire. Results were compared, and multivariable analysis was performed to identify predictors of outcome. RESULTS: Seventy-one patients (98%) were evaluated at enrollment and 66 (92%) at 1 year. Compared with baseline, no significant differences were found on Fecal Incontinence Severity Index scores at 1 year. Fecal Incontinence Quality of Life results were significantly worse in the lifestyle (p < 0.001), coping/behavior (p < 0.001), and embarrassment (p = 0.002) domains. There were no differences in the Functional Assessment of Cancer Therapy overall score, but the physical well-being subscale was significantly worse and emotional well-being was improved after surgery. Treatment with the original chemoradiation regimen predicted worse depression/self-perception and embarrassment scores in the Fecal Incontinence Quality of Life, and male sex was predictive of worse scores in the Functional Assessment of Cancer Therapy overall score and trial outcome index. LIMITATIONS: Small sample size, relatively short follow-up, and absence of information before cancer diagnosis were study limitations. CONCLUSIONS: Chemoradiation followed by local excision had minimal impact on anorectal function 1 year after surgery. Overall quality of life remained stable, with mixed effects on different subscales. This information should be used to counsel patients about expected outcomes.

Fecal incontinence treated by sacral neuromodulation: Long-term follow-up of 325 patients.

BACKGROUND: Long-term results of large patient cohorts with fecal incontinence treated by sacral neuromodulation are limited. This study shows the long-term results after a mean follow-up of 7.1 years in 325 patients with fecal incontinence treated by continuous sacral neuromodulation. METHODS: All patients with fecal incontinence and eligible for sacral neuromodulation between 2000 and 2015 were evaluated retrospectively. Primary outcome was a decrease in episodes of fecal incontinence, which was defined as involuntary fecal loss at least once per week and documented by a 3 week bowel habit diary. Quality of life was assessed using the Short-Form 36 and the Fecal Incontinence Quality of Life Score. RESULTS: In the study, 374 patients were included for sacral neuromodulation screening and 325 patients (32 male, 9.7%) received permanent, continuous sacral neuromodulation. Mean age was 56.5 years (17-82 years) and mean follow-up was 7.1 years (3.0-183.4 months). In the 325 patients with permanent sacral neuromodulation, fecal incontinence episodes decreased from a mean of 16.1 ± 14.5 to 3.0 ± 3.7 per 3-week period after sacral neuromodulation (P < .001) according to the bowel habit diary. Sacral neuromodulation was removed due to unsatisfactory results in 81 patients. Quality of life (both Short-Form 36 and Fecal Incontinence Quality of Life Score) showed no significant difference compared with the Dutch population during follow-up. CONCLUSION: Long-term efficacy of sacral neuromodulation can be maintained in about half (52.7%) of all patients screened with sacral neuromodulation for fecal incontinence after a mean follow-up of 7.1 years. Importantly, the quality of life of patients with sacral neuromodulation for fecal incontinence did not differ from the general population.

Integrated low-intensity biofeedback therapy in fecal incontinence: evidence that "good" in-home anal sphincter exercise practice makes perfect.

BACKGROUND: Biofeedback therapy (BFT) is an established treatment for fecal incontinence (FI), with access often being restricted to tertiary centers due to resources and the perceived requirement for high-intensity regimes. However, the optimal regime remains unknown. We evaluated outcomes from our low-intensity integrated BFT program in a secondary care center. METHODS: Outcomes of our BFT service for FI were evaluated retrospectively. Response was defined by ≥50% improvement in FI frequency from baseline or complete continence. Responders were compared to non-responders for factors including symptoms, manometry data, sphincter exercise technique and duration of practice, and the number and frequency of sessions. Where patients dropped out, outcomes and the reason for dropout were obtained retrospectively. KEY RESULTS: Fecal incontinence patients (n=205, median 62 years, 72% female) attended a median (IQR) 3 (2) BFT sessions with 55 (36) days between visits. Overall, 146/205 (71%) responded with 97/205 (47%) achieving continence. Fecal incontinence frequency improved dramatically in completed cases (P=0.000). While non-response was associated with males (P=0.03) and dropout (P=0.000), "good" anal sphincter exercise technique (P=0.008) and longer in-home practice (P=0.007) and more sessions (P=0.04) were associated with response. Dropout rate was 80/205 (39%), with the reason for dropout being obtained in 80%. CONCLUSIONS & INFERENCES: Despite low-intensity BFT, comparable outcomes to data from tertiary centers were achieved. Our data emphasize the importance of technique and in-home practice of anal sphincter exercises. Customizing BFT intensity based on predictive factors and encouraging in-home practice may optimize outcomes, reduce dropout rates, and rationalize resources.