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Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
NCT03149809 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03149809 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Alabama, Georgia, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03149809?
The interventions under investigation include: solifenacin (DRUG), Pelvic floor muscle exercise-based behavioral therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03149809?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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