Stimulation of the tibial nerve—a randomised trial for urinary problems associated with Parkinson’s—the STARTUP trial

McClurg, Doreen, Elders, Andrew, Hagen, Suzanne, Mason, Helen, Booth, Jo, Cunnington, Anne-Louise, Walker, Richard, Deane, Katherine, Harari, Danielle, Panicker, Jalesh, Stratton, Susan, McArthur, Jaclyn, Sellers, Ceri and Collins, Marissa (2022) Stimulation of the tibial nerve—a randomised trial for urinary problems associated with Parkinson’s—the STARTUP trial. Age and Ageing, 51 (6). ISSN 0002-0729

[img]
Preview
PDF (afac114) - Published Version
Available under License Creative Commons Attribution.

Download (623kB) | Preview

Abstract

Background: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson’s increasing the risk for falls with a negative impact on health-related costs and quality of life. We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson’s disease (PD). Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device. The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. Results: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%. There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size −1.49, 95% CI −2.72, −0.25). There was no statistically significant change in any other outcome. Conclusion: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

Item Type: Article
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Depositing User: LivePure Connector
Date Deposited: 22 Jun 2022 10:30
Last Modified: 23 Jun 2022 11:31
URI: https://ueaeprints.uea.ac.uk/id/eprint/85744
DOI: 10.1093/ageing/afac114

Actions (login required)

View Item View Item