Effectiveness of electrical stimulation with conservative treatment for lower urinary tract symptoms in Parkinson's disease: A three-armed randomized controlled trial protocol

This randomized controlled trial includes three study arms. All three groups will receive conservative treatment in combination with different electrical stimulation parameters, small- and broad pulse duration and sham electrical stimulation. In total 150 PD patients with self-reported LUTS who are able to attend a pelvic physical therapy practice independently and complete online questionnaires will be enrolled. The primary outcome is the difference in international prostate symptom score (IPSS), with a range of 0-35.A minimal important difference of 4.2 between baseline and 12 weeks of treatment will be statistical significant (p˂0.05). Secondary outcome include questionnaires evaluating bladder dysfunction, burden, and quality of life and will be collected at baseline, 12 weeks and 24 weeks and at one year. Additionally pelvic floor muscle function will be assed at baseline and after 12 weeks.All participants receive eight sessions along with their assigned electrical stimulation treatment and conservative treatment.

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Publication Details

Journal
Contemporary Clinical Trials Communications
Published
2025-04-01
DOI
https://doi.org/10.1016/j.conctc.2025.101480
Primary Topic
Urinary Bladder and Prostate Research
Type
article
Field-Weighted Citation Impact
0.00

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article

Effectiveness of electrical stimulation with conservative treatment for lower urinary tract symptoms in Parkinson's disease: A three-armed randomized controlled trial protocol

Dagmar H. Hepp, Henk W. Elzevier, Maxime T. M. Kummeling, Anton A. van der Plas et al.
Contemporary Clinical Trials Communications
Urinary Bladder and Prostate Research
article

Effectiveness of electrical stimulation with conservative treatment for lower urinary tract symptoms in Parkinson's disease: A three-armed randomized controlled trial protocol

Dagmar H. Hepp, Henk W. Elzevier, Maxime T. M. Kummeling, Anton A. van der Plas, Rob A. de Bie, Heidi F. A. Moossdorff-Steinhauser, Dorien Bennink, Hein Putter, Gommert Anton van Koeveringe
article en

Abstract

This randomized controlled trial includes three study arms. All three groups will receive conservative treatment in combination with different electrical stimulation parameters, small- and broad pulse duration and sham electrical stimulation. In total 150 PD patients with self-reported LUTS who are able to attend a pelvic physical therapy practice independently and complete online questionnaires will be enrolled. The primary outcome is the difference in international prostate symptom score (IPSS), with a range of 0-35.A minimal important difference of 4.2 between baseline and 12 weeks of treatment will be statistical significant (p˂0.05). Secondary outcome include questionnaires evaluating bladder dysfunction, burden, and quality of life and will be collected at baseline, 12 weeks and 24 weeks and at one year. Additionally pelvic floor muscle function will be assed at baseline and after 12 weeks.All participants receive eight sessions along with their assigned electrical stimulation treatment and conservative treatment.

Contemporary Clinical Trials CommunicationsVol. 45
Leiden University Medical Center (NL), Maastricht University Medical Centre (NL), Maastricht University (NL), Alrijne Ziekenhuis (NL), Department of Health (TW)
Koninklijk Nederlands Genootschap voor Fysiotherapie, Hersenstichting
Good health and well-being
Openalex Percentile: Top 92%
Urinary Bladder and Prostate Research
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