Transcutaneous tibial nerve stimulation for overactive bladder symptoms in Parkinson’s disease: results from a phase II randomised control trial (STRIPE)
Author(s)
Type
Journal Article
Abstract
Background
Lower urinary tract symptoms (LUTS) are common Parkinson's disease (PD), causing great impact.
Objective
The goal was to undertake a phase II randomized control trial of transcutaneous tibial nerve stimulation (TTNS) delivered by Geko device for LUTS related to overactive bladder (OAB) in PD, an easy to use of the shelf solution.
Methods
Participants were randomized to active/sham stimulation. Primary outcome measure was the International Consultation on Incontinence Questionnaire-Overactive Bladder score (ICIQ-OAB) at 12 weeks.
Results
A total of 148 participants were allocated to active (73) and sham arms (75). No difference was seen between arms (coefficient, 0.48; 95% CI, −0.2 to 1.2; P = 0.17), although both active and sham showed improvements over baseline. Pain was the most common adverse event.
Conclusion
No difference was seen between active and sham arms. Symptom improvements seen in both groups are consistent with a placebo effect, however, we cannot exclude a biological effect from the sham intervention. Although negative, this result should be taken only in context of Geko use rather TTNS in general. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Lower urinary tract symptoms (LUTS) are common Parkinson's disease (PD), causing great impact.
Objective
The goal was to undertake a phase II randomized control trial of transcutaneous tibial nerve stimulation (TTNS) delivered by Geko device for LUTS related to overactive bladder (OAB) in PD, an easy to use of the shelf solution.
Methods
Participants were randomized to active/sham stimulation. Primary outcome measure was the International Consultation on Incontinence Questionnaire-Overactive Bladder score (ICIQ-OAB) at 12 weeks.
Results
A total of 148 participants were allocated to active (73) and sham arms (75). No difference was seen between arms (coefficient, 0.48; 95% CI, −0.2 to 1.2; P = 0.17), although both active and sham showed improvements over baseline. Pain was the most common adverse event.
Conclusion
No difference was seen between active and sham arms. Symptom improvements seen in both groups are consistent with a placebo effect, however, we cannot exclude a biological effect from the sham intervention. Although negative, this result should be taken only in context of Geko use rather TTNS in general. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Date Issued
2025-07-01
Date Acceptance
2025-03-13
Citation
Movement Disorders, 2025, 40 (7), pp.1291-1296
ISSN
0885-3185
Publisher
Wiley
Start Page
1291
End Page
1296
Journal / Book Title
Movement Disorders
Volume
40
Issue
7
Copyright Statement
© 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
License URL
Identifier
10.1002/mds.30186
Subjects
autonomic
bladder
neuromodulation
overactive
Parkinson's
Publication Status
Published
Date Publish Online
2025-04-17