Dataset Information

Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment.

ABSTRACT:

Objective

To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance.

Methods

This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. They underwent 12 sessions of 30-min TENS application and were assigned to five groups: one leg, once a week (n=26); one leg, twice a week (n=27); two legs, once a week (n=26); two legs, twice a week (n=28); and placebo (n=30). Symptoms of overactive bladder and its impact on quality of life were evaluated before and after 6 or 12 weeks of treatment using the Overactive Bladder Questionnaire-V8 and voiding diary. ClinicalTrials.gov: NCT01912885.

Results

The use of one leg, once a week TENS application reduced the frequency of urgency episodes compared with the placebo (1.0±1.6 vs. 1.4±1.9; p=0.046) and frequency of incontinence episodes compared with the placebo (0.7±1.4 vs.1.4±2.2; p<0.0001). The one-leg, twice a week protocol decreased the urinary frequency compared with the two legs, once a week protocol (8.2±3.5 vs. 9.0±5.1; p=0.026) and placebo (8.2±3.5 vs. 7.9±2.7; p=0.02). Nocturia improved using the two legs, once a week protocol (1.5±1.8) when compared with the one leg, twice a week protocol (1.9±2.0) and placebo (1.7±1.6) (p=0.005 and p=0.027, respectively). Nocturia also improved using the two legs, twice a week protocol when compared with the one leg, twice a week protocol (1.3±1.2 vs.1.9±2.0; p=0.011).

Conclusion

One-leg stimulation improved the daily urinary frequency, urgency, and incontinence, and the two-leg stimulation once and twice weekly improved nocturia.

SUBMITTER: Pierre ML

PROVIDER: S-EPMC8341038 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:Background: Neurogenic lower urinary tract dysfunction (NLUTD) is common among people with multiple sclerosis (MS) with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive option to manage bladder storage symptoms; however, the potential efficacy of TTNS among people with MS is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS. Methods: We will use a single-arm experimental study to explore the feasibility and acceptability of TTNS in the treatment of bladder storage symptoms in MS. The CONSORT extension for pilot and feasibility studies will be followed to standardise the conduct and reporting of the study. The recruitment plan is twofold: 1) Open recruitment for people with MS through MS Ireland's communication channels; 2) recruitment from a convenience sample of people with MS who have previously participated in a qualitative interview study of urinary symptoms. We will assess recruitment/retention rates, the urinary symptoms changes and the effect on quality of life pre and post intervention using ICIQ-OAB, 3-day bladder diary, King's Health Questionnaire and collect self-reported data on adherence and adverse events. Acceptability of using TTNS will be evaluated at the end of intervention. This study has been reviewed and approved by the Education and Health Science's Faculty Research Ethics Committee, University of Limerick [2020_06_07_EHS]. Conclusion: It is anticipated that assessing the feasibility and acceptability of TTNS for storage bladder symptoms in MS will inform the development of a definitive randomised trial. Trial registration: ClinicalTrials.gov NCT04528784 27/08/2020.

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