Dataset Information

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

ABSTRACT:

Introduction

We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients.

Methods

We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant.

Results

We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups.

Conclusions

TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.

SUBMITTER: Welk B

PROVIDER: S-EPMC7337720 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Publications

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

Welk Blayne B McKibbon Mary M

Canadian Urological Association journal = Journal de l'Association des urologues du Canada 20200701 7

<h4>Introduction</h4>We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients.<h4>Methods</h4>We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three ti ...[more]

PMID: 32017693

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Project description:BackgroundOveractive bladder (OAB) is a problem that increasingly affects adults and the elderly, especially women. It may affect quality of life, ability to participate and overall wellbeing. Transcutaneous tibial nerve stimulation (TTNS) is a form of neuromodulation involving the use of electrical impulses to address urinary symptoms. There are many randomized controlled trials that have shown that TTNS is effective at treating overactive bladder. In recent years, TTNS has gained increasing attention for this condition. But its effect in females remains controversial and evidence is lacking. Therefore, the main purpose of this study will be to systematically evaluate the effect of TTNS on females with OAB in Multiple sclerosis (MS) by conducting a systematic review and meta-analysis, and also to provide a reference for the application of TTNS in OAB.MethodsA systematic review of eligible articles will be conducted using Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. A comprehensive search of the literature will be conducted in PubMed, Web of Science, The Cochrane Library, Chinese National Knowledge Infrastructure Database (CNKI), Wanfang Data, Weipu Electronics, and other databases. We will include randomized controlled trials about TTNS in females with OAB in MS. Two reviewers will screen titles, abstracts, and full texts independently. We will use a hierarchy of recommended assessment, development, and assessment methods to assess the overall certainty of the evidence and report findings accordingly. Endnote X9 will be used to select the studies and Review Manager V.5.4 (Cochrane Collaboration) will be used to conduct the meta-analysis. The mean difference or standard deviation with 95% confidence interval (CI) will be used in the computation of continuous variables to synthesize data.ResultsThe results will provide evidence for judging whether TTNS is effective in females with OAB and MS.ConclusionThis study will provide reliable evidence for the effect of TTNS in female patients with OAB and MS.Trial registrationSystematic review registration: PROSPERO CRD42021256861.

Project description:BackgroundTranscutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham-controlled trials have been conducted in a pediatric population. To our knowledge, both therapies never have been compared in children.AimThe aim of the complete study is twofold: (1) to assess the efficacy of TTNS therapy on bladder symptoms after 12 weeks of treatment in a pediatric population with idiopathic overactive bladder syndrome (iOAB) and/or nocturnal enuresis (part I) and (2) to assess the effect of TTNS compared to PTNS (part II). In this article, we aim to present the protocol of the first part of the TaPaS trial (TTNS, PTNS, sham therapy).MethodsPart I of the TaPaS trial is set up as a single-center randomized-controlled trial. Children, aged from 5 to 12 years with iOAB and/or nocturnal enuresis, are assigned to two groups by computer-generated randomization: TTNS therapy (intervention) and sham therapy (control). The primary outcome is the percentage difference in average voided volume (AVV) between baseline and after 12 weeks of treatment. Secondary endpoints are the percentage difference in supervoid volumes, number of urinary incontinence episodes/24 h and in voiding frequency, the difference in parent reported outcomes between baseline and after 12 weeks of treatment, and the duration of clinical response.DiscussionWe hypothesize that TTNS is a non-inferior treatment for iOAB in children compared to PTNS therapy. Since literature is inconclusive about the efficacy of TTNS in a pediatric population, a sham-controlled RCT on TTNS will be conducted (part I). A protocol for a prospective randomized sham-controlled trial has been developed. Enrolment has started in November 2018. Study completion of part I is expected by August 2021.Trial registrationClinicalTrials.gov NCT04256876 . Retrospectively registered on February 5, 2020.

Project description:BackgroundMultiple Sclerosis (MS) is an often debilitating disease affecting the myelin sheath that encompasses neurons. It can be accompanied by a myriad of pathologies and adverse effects such as neurogenic lower urinary tract dysfunction (NLUTD). Current treatment modalities for resolving NLUTD focus mainly on alleviating symptoms while the source of the discomfort emanates from a disruption in brain to bladder neural circuitry. Here, we leverage functional magnetic resonance imaging (fMRI), repetitive transcranial magnetic stimulation (rTMS) protocols and the brains innate neural plasticity to aid in resolving overactive bladder (OAB) symptoms associated with NLUTD.MethodsBy employing an advanced neuro-navigation technique along with processed fMRI and diffusion tensor imaging data to help locate specific targets in each participant brain, we are able to deliver tailored neuromodulation protocols and affect either an excitatory (20 min @ 10 Hz, applied to the lateral and medial pre-frontal cortex) or inhibitory (20 min @ 1 Hz, applied to the pelvic supplemental motor area) signal on neural circuitry fundamental to the micturition cycle in humans to restore or reroute autonomic and sensorimotor activity between the brain and bladder. Through a regimen of questionnaires, bladder diaries, stimulation sessions and analysis, we aim to gauge rTMS effectiveness in women with clinically stable MS.DiscussionSome limitations do exist with this study. In targeting the MS population, the stochastic nature of MS in general highlights difficulties in recruiting enough participants with similar symptomology to make meaningful comparisons. As well, for this neuromodulatory approach to achieve some rate of success, there must be enough intact white matter in specific brain regions to receive effective stimulation. While we understand that our results will represent only a subset of the MS community, we are confident that we will accomplish our goal of increasing the quality of life for those burdened with MS and NLUTD.Trial registrationThis trial is registered at ClinicalTrials.gov (NCT06072703), posted on Oct 10, 2023.

Dataset Information

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

Introduction

Methods

Results

Conclusions

Publications

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

Similar Datasets

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