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.
Authors
- Dagmar H. Hepp (ORCID: https://orcid.org/0000-0001-9214-3735)
- Henk W. Elzevier (ORCID: https://orcid.org/0000-0001-9636-0200)
- Maxime T. M. Kummeling (ORCID: https://orcid.org/0000-0001-8834-071X)
- Anton A. van der Plas (ORCID: https://orcid.org/0000-0002-8737-478X)
- Rob A. de Bie (ORCID: https://orcid.org/0000-0001-5882-9303)
- Heidi F. A. Moossdorff-Steinhauser (ORCID: https://orcid.org/0000-0002-9651-1731)
- Dorien Bennink
- Hein Putter (ORCID: https://orcid.org/0000-0001-5395-1422)
- Gommert Anton van Koeveringe (ORCID: https://orcid.org/0000-0003-2328-8265)
Institutions
- Leiden University Medical Center (NL)
- Maastricht University Medical Centre (NL)
- Maastricht University (NL)
- Alrijne Ziekenhuis (NL)
- Department of Health (TW)
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
Funders
- Koninklijk Nederlands Genootschap voor Fysiotherapie
- Hersenstichting