Dataset Information

Effects of transcutaneous tibial nerve stimulation on females with overactive bladder syndrome in multiple sclerosis a protocol for a systematic review and meta-analysis.

ABSTRACT:

Background

Overactive 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.

Methods

A 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.

Results

The results will provide evidence for judging whether TTNS is effective in females with OAB and MS.

Conclusion

This study will provide reliable evidence for the effect of TTNS in female patients with OAB and MS.

Trial registration

Systematic review registration: PROSPERO CRD42021256861.

SUBMITTER: Tu H

PROVIDER: S-EPMC9333199 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundNeurogenic lower urinary tract dysfunction is an abnormality in the presence of underlying neurologic disease. A recent systematic review and meta-analysis demonstrated that storage phase symptoms are the predominant symptoms among people with multiple sclerosis (PwMS). Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment for bladder storage symptoms; however, the potential efficacy of stimulation among PwMS is based on a small number of studies with the absence of high-quality evidence. The aim of this study was to evaluate the feasibility, acceptability, and safety of TTNS in PwMS using an affordable transcutaneous electrical nerve stimulation (TENS) unit.MethodsA total of 23 participants with MS enrolled in the study. The primary outcomes included recruitment/retention rate, completion of the outcomes and the intervention, adherence to the protocol, adverse events, and acceptability of the intervention. The primary outcomes were assessed using diaries and a satisfaction questionnaire. The secondary outcomes included changes in urinary symptoms and quality of life assessed using a set of validated outcome measures including a 3-day bladder diary, PPIUS, ICIQ-OAB, and KHQ at baseline and post-intervention.ResultsTwenty participants completed the study. Three participants (13.04%) withdrew. All 20 participants completed the 6-week intervention and all the outcome measures (100%), with no reported adverse events. Participants were satisfied and found the unit acceptable. Three-day bladder diary showed changes in urinary frequency from a daily median of 10 times to 8 times and daily median urgency changed from 6 times at baseline to 2 times post-intervention. PPIUS showed changes in daily median sever urgency from 3 points (IQR=4) to 1 point (IQR=1) post-intervention. ICIQ-OAB total scores changed from 8 points (IQR=2.25) to 4 points (IQR=2.5) post-intervention. Median and mean scores of KHQ showed a clinical meaningful change of QoL in part-two and part-three of the questionnaire.ConclusionsTTNS is feasible, safe, and acceptable for PwMS. Changes of urinary symptoms scores and QoL post-intervention suggested improvements. Future implications need to consider the treatment protocol including frequency of treatment sessions, duration of treatment, and the electrical stimulation parameters as well as the outcome measures followed in the current study for the implementation of the future pilot RCT.Trial registrationClinicalTrials.gov NCT04528784 . Registered on 27 August 2020. https://register.Clinicaltrialsgov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4 .

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