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Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study.

ABSTRACT: 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.

SUBMITTER: Al Dandan HB

PROVIDER: S-EPMC7578569 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study.

Al Dandan Hawra B HB Galvin Rose R Robinson Katie K McClurg Dorren D Coote Susan S

HRB open research 20200916

<b>Background:</b> 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 ...[more]

PMID: 33117961

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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 .

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: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.

Dataset Information

Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study.

Publications

Transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms in people with multiple sclerosis: Protocol of a single-arm feasibility study.

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