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NCT03149809 · ClinicalTrials.gov registry record · Phase 3
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
A Phase 3 study of Parkinson Disease and Overactive Bladder, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
- 4
- Study locations
NCT03149809 is a Phase 3 study of Parkinson Disease and Overactive Bladder that has completed, run by VA Office of Research and Development. The registered enrollment target is 77 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT03149809, a Phase 3 study of Parkinson Disease and Overactive Bladder, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
- 4
- Study locations
Study Summary
The impact of urinary symptoms in Parkinson disease (PD) extends beyond worsened well-being. Urinary symptoms common in PD, especially incontinence and nocturia, are major risk factors for falls likely due to the combination of urinary urgency and impaired mobility (and falls are a leading cause of mortality in PD), for spouse/caregiver stress due to decreased mutuality in the relationship, and for institutionalization, largely due to increased disability. Additionally, most medications currently recommended for urinary symptoms in PD are anticholinergic and have the potential to worsen the progressive cognitive and autonomic burdens of the disease. Veterans with PD are also more likely to rely solely on VA for their health care than Veterans without PD. Thus, optimizing the care of urinary symptoms for Veterans with PD becomes imperative, particularly for VA. Using a non-inferiority design, this proposal seeks to demonstrate the comparative effectiveness of pelvic floor muscle exercise-based behavioral therapy versus drug therapy to treat urinary symptoms in PD.
Conditions Studied
Interventions
- DRUG solifenacin
- BEHAVIORAL Pelvic floor muscle exercise-based behavioral therapy
Study Locations (4)
Alabama
- Birmingham VA Medical Center, Birmingham, AL - Birmingham
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03149809
The ClinicalTrials.gov registry entry for NCT03149809 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which solifenacin is the first listed.
NCT03149809 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Alabama, Georgia, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03149809 about?
NCT03149809 is a clinical study titled "Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease". The impact of urinary symptoms in Parkinson disease (PD) extends beyond worsened well-being. Urinary symptoms common in PD, especially incontinence and nocturia, are major risk factors for falls likely due to the combination of urinary urgency and impaired mobility (and falls are a leading cause of ...
What is the current status of trial NCT03149809?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2018-03-01. Estimated completion is 2023-09-08.
What conditions does trial NCT03149809 study?
This clinical trial studies the following conditions: Parkinson Disease, Overactive Bladder.
What interventions are being tested in trial NCT03149809?
The interventions under investigation include: solifenacin (DRUG), Pelvic floor muscle exercise-based behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03149809?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03149809 being conducted?
This trial has 4 study locations across Alabama, Georgia, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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