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Randomized Controlled Trial
. 2022 Jun 1;51(6):afac114.
doi: 10.1093/ageing/afac114.

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

Doreen McClurg  1 , Andrew Elders  1 , Suzanne Hagen  1 , Helen Mason  2 , Jo Booth  3 , Anne-Louise Cunnington  4 , Richard Walker  5 , Katherine Deane  6 , Danielle Harari  7 , Jalesh Panicker  8 , Susan Stratton  1 , Jaclyn McArthur  2 , Ceri Sellers  1 , Marissa Collins  2
Affiliations
Randomized Controlled Trial

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

Doreen McClurg et al. Age Ageing. .

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.

Keywords: Parkinson’s; bladder dysfunction; neurology; neuromodulation; older people.

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Comment in

  • Geriatrics.
    Griebling TL. Griebling TL. J Urol. 2023 Aug;210(2):362-365. doi: 10.1097/JU.0000000000003524. Epub 2023 May 9. J Urol. 2023. PMID: 37157786 No abstract available.

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