Movement disorders : official journal of the Movement Disorder Society · 2025
Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Parkinson's Disease: Results from a Phase II Randomized Control Trial (STRIPE).
СтатьяКлиническое исследование II фазыРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Smith Matthew D, Portlock Gabriella E, Cullen Anisha, Nodehi Anahita, Drake Marcus J, Ben-Shlomo Yoav, Henderson Emily J
Аннотация
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.
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.