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A novel combined anorectal biofeedback and percutaneous tibial nerve stimulation protocol for treating fecal incontinence.

ABSTRACT: Background/Aims:Fecal incontinence (FI) is a common, debilitating condition that causes major impact on quality of life for those affected. Non-surgical treatment options include anorectal biofeedback therapy (BF) and percutaneous tibial nerve stimulation (PTNS), usually performed separately. The aims of the current study were to determine the feasibility, tolerability, safety, and efficacy of performing a combined BF and PTNS treatment protocol. Methods:Female patients with urge FI were offered a novel pilot program combining BF with PTNS. The treatment protocol consisted of 13 weekly sessions: an educational session, followed by 5 combined BF and PTNS sessions, 6 PTNS and a final combined session. Anorectal physiology and clinical outcomes were assessed throughout the program. For efficacy, patients were compared with BF only historical FI patients matched for age, parity, and severity of symptoms. Results:A total of 12/13 (93%) patients completed the full program. Overall attendance rate was 93% (157/169 sessions). Patient comfort score with treatment was rated high at 9.8/10 (SD 0.7) for PTNS and 8.6/10 (SD 1.7) for the BF component. No major side effects were reported. A reduction of at least 50% in FI episodes/week was achieved by 58% of patients by visit 6, and 92% by visit 13. No physiology changes were evident immediately following PTNS compared with before, but pressure during sustained anal squeeze improved by the end of the treatment course. Comparing outcomes with historical matched controls, reductions in weekly FI episodes were more pronounced in the BF only group at visit 6, but not week 13. Conclusions:In this pilot study, concurrent PTNS and anorectal biofeedback therapy has been shown to be feasible, comfortable, and low risk. The combined protocol is likely to be an effective treatment for FI, but future research could focus on optimizing patient selection.

SUBMITTER: Mazor Y

PROVIDER: S-EPMC7288816 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A novel combined anorectal biofeedback and percutaneous tibial nerve stimulation protocol for treating fecal incontinence.

Mazor Yoav Y Prott Gillian M GM Sequeira Carol C Jones Michael M Ejova Anastasia A Kellow John E JE Schnitzler Margaret M Malcolm Allison A

Therapeutic advances in gastroenterology 20200610

<h4>Background/aims</h4>Fecal incontinence (FI) is a common, debilitating condition that causes major impact on quality of life for those affected. Non-surgical treatment options include anorectal biofeedback therapy (BF) and percutaneous tibial nerve stimulation (PTNS), usually performed separately. The aims of the current study were to determine the feasibility, tolerability, safety, and efficacy of performing a combined BF and PTNS treatment protocol.<h4>Methods</h4>Female patients with urge ...[more]

PMID: 32577132

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Project description:BackgroundThe aim of the present study was to evaluate the long-term efficacy of percutaneous tibial nerve stimulation (PTNS) for patients with faecal incontinence (FI) refractory to conservative treatment. Secondary aims were to identify predictors of response and validate new treatment pathways for partial responders.MethodsA prospective, interventional study was carried out in a specialist defecatory disorder unit from a university hospital between January 2010 and June 2017 on patients > 18 years old with FI refractory to conservative treatment. Thirty-minute PTNS sessions were performed in three phases (weekly, biweekly and monthly) up to a year, with clinical reassessment at 3, 6, 12 and 36 months. Patients were classified as optimal responders when their pretreatment Wexner score decreased > 50%; partial responders when it decreased 25-50%; and insufficient responders if it decreased < 25%. Only optimal and partial responders progressed into successive phases.ResultsBetween 2010 and 2017, 139 patients (110 women, median age 63 years [range 22-82 years]) were recruited. After the first phase, 4 patients were optimal responders, 93 were partial responders and 36 were insufficient responders. At 6 and 12 months, 66 and 89 patients respectively were optimal responders, with an optimal response rate of 64% at the end of treatment. A total of 93.3% patients with a partial response initially finally became optimal responders. Furthermore, at 36 months, 71.9% of patients were still optimal responders without supplementary treatment, although their quality of life did not improve significantly. Baseline Wexner scores ≤ 10 and symptom duration < 1 year were identified as predictive factors for positive responses to PTNS.ConclusionsPatients undergoing PTNS for 1 year following this protocol had optimal long-term responses. PTNS sessions for up to 1 year in patients who were partial responders prevents a high percentage of them from needing more invasive treatments, and maintains long-term continence in patients who were optimal responders.

Project description:PurposeThis systematic review determines the best known form of biofeedback (BF) and/or electrical stimulation (ES) for the treatment of fecal incontinence in adults and rates the quality of evidence using the Grades of Recommendation, Assessment, Development, and Evaluation. Attention is given to type, strength, and application mode of the current for ES and to safety.MethodsMethods followed the Cochrane Handbook. Randomized controlled trials were included. Studies were searched in The Cochrane Library, MEDLINE, and EMBASE (registration number (PROSPERO): CRD42011001334).ResultsBF and/or ES were studied in 13 randomized parallel-group trials. In 12 trials, at least one therapy group received BF alone and/or in combination with ES, while ES alone was evaluated in seven trials. Three (four) trials were rated as of high (moderate) quality. Average current strength was reported in three of seven studies investigating ES; only two studies reached the therapeutic window. No trial showed superiority of control, or of BF alone or of ES alone when compared with BF + ES. Superiority of BF + ES over any monotherapy was demonstrated in several trials. Amplitude-modulated medium-frequency (AM-MF) stimulation, also termed pre-modulated interferential stimulation, combined with BF was superior to both low-frequency ES and BF alone, and 50 % of the patients were continent after 6 months of treatment. Effects increased with treatment duration. Safety reporting was bad, and there are safety issues with some forms of low-frequency ES.ConclusionsThere is sufficient evidence for the efficacy of BF plus ES combined in treating fecal incontinence. AM-MF plus BF seems to be the most effective and safe treatment.Key messages• The higher the quality of the randomized trial the more likely was a significant difference between treatment groups. • Two times more patients became continent when biofeedback was used instead of a control, such as pelvic floor exercises. • Two times more patients became continent when biofeedback plus electrical stimulation was used instead of biofeedback only. • Low-frequency electrical stimulation can have adverse device effects, and this is in contrast to amplitude-modulated medium-frequency electrical stimulation. • There is high quality evidence that amplitude-modulated medium-frequency electrical stimulation plus electromyography biofeedback is the best second-line treatment for fecal incontinence.

Project description:BackgroundUrinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents' dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences.MethodsThis is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers.DiscussionTPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication.Trial registrationClinicalTrials.gov, NCT03248362. Registered on 14 August 2017. ISRCTN, ISRCTN98415244. Registered on 25 April 2018. https://www.isrctn.com/.

Project description:BackgroundBladder symptoms are common in Parkinson's disease (PD), affecting half of all individuals. These have significant impact on quality of life as well as implications for morbidity, contributing to falls and hospital admission. The treatment of bladder symptoms can be complicated by the tendency to side-effects in people with PD including cognitive impairment and gait instability with anti-muscarinics. The development of new, better treatments is therefore warranted. Tibial nerve stimulation is a form of neuromodulation demonstrated to improve overactive bladder symptoms in non-neurogenic cohorts. Previously requiring hospital attendance, we aim to explore the use of this intervention using a simple device that can be used by patients at home.MethodsSTRIPE is a phase II randomised control trial of tibial nerve stimulation delivered by the Geko™ device, a small, self-adhesive neuromuscular stimulation device currently used for thromboembolism prophylaxis post-surgery. Active tibial nerve stimulation will be compared to sham stimulation, with participants blinded to treatment allocation and undertaking outcome assessment whilst still blinded. Participants will be asked to self-administer stimulation at home twice per week, for 30 min per session, over the course of 3 months. Primary outcome measure will be the International Consultation on Incontinence Overactive Bladder Questionnaire (OAB) at week 12. Secondary outcomes will include pre- and post-intervention bladder diary (frequency, urgency episodes, nocturia), patient perception of global change, bowel function and bladder-related quality of life. Participants will be recruited from the Proactive Integrated Management and Empowerment (PRIME) cross-sectional trial in which participants have been screened for bladder symptoms and invited to take part, as well as clinician referral from around the region.DiscussionThis trial will involve a randomised control trial of a novel and easy to use method of delivering tibial nerve stimulation for PD in the patient's own home. This may potentially have huge benefit, avoiding the problems with side effects that can be seen with anti-muscarinics and providing a new potential modality of treatment.Trial registrationISRCTN11484954. Registered on 22 June 2021.

Project description:Background & aimsThree-dimensional high-definition anorectal manometry (3D-HDAM) is used to assess anal sphincter function; it determines profiles of regional pressure distribution along the length and circumference of the anal canal. There is no consensus, however, on the best way to analyze data from 3D-HDAM to distinguish healthy individuals from persons with sphincter dysfunction. We developed a computer analysis system to analyze 3D-HDAM data and to aid in the diagnosis and assessment of patients with fecal incontinence (FI).MethodsIn a prospective study, we performed 3D-HDAM analysis of 24 asymptomatic healthy subjects (control subjects; all women; mean age, 39 ± 10 years) and 24 patients with symptoms of FI (all women; mean age, 58 ± 13 years). Patients completed a standardized questionnaire (FI severity index) to score the severity of FI symptoms. We developed and evaluated a robust prediction model to distinguish patients with FI from control subjects using linear discriminant, quadratic discriminant, and logistic regression analyses. In addition to collecting pressure information from the HDAM data, we assessed regional features based on shape characteristics and the anal sphincter pressure symmetry index.ResultsThe combination of pressure values, anal sphincter area, and reflective symmetry values was identified in patients with FI versus control subjects with an area under the curve value of 1.0. In logistic regression analyses using different predictors, the model identified patients with FI with an area under the curve value of 0.96 (interquartile range, 0.22). In discriminant analysis, results were classified with a minimum error of 0.02, calculated using 10-fold cross-validation; different combinations of predictors produced median classification errors of 0.16 in linear discriminant analysis (interquartile range, 0.25) and 0.08 in quadratic discriminant analysis (interquartile range, 0.25).ConclusionsWe developed and validated a novel prediction model to analyze 3D-HDAM data. This system can accurately distinguish patients with FI from control subjects.

Dataset Information

A novel combined anorectal biofeedback and percutaneous tibial nerve stimulation protocol for treating fecal incontinence.

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A novel combined anorectal biofeedback and percutaneous tibial nerve stimulation protocol for treating fecal incontinence.

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