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NCT01520948 · ClinicalTrials.gov registry record · Phase 3
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
A Phase 3 study, sponsored by Atlanta VA Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT01520948: Completed Phase 3 study, sponsored by Atlanta VA Medical Center.
NCT01520948 is a Phase 3 study that has completed, run by Atlanta VA Medical Center. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01520948, a Phase 3 study, has completed, sponsored by Atlanta VA Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI), urgency, and/or nocturia, are common non-motor symptoms that further diminish the already compromised quality of life for adults living with PD. Behavioral interventions for UI - including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized controlled trials and are free of side effects. Exercise-based behavioral therapy for UI requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral strategy that incorporates the PFME to suppress urinary urgency and prevent UI. We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month follow-up is planned in the treatment group. We hypothesize that: 1. PD participants who are randomized to the exercise-based behavioral therapy group (Group A) will report a significant reduction in weekly frequency of UI episodes compared to PD participants in the behavioral control group (Group B). The primary outcome, frequency of UI, will be measured using a seven-day bladder diary. 2. Compared to PD participants in Group B, the reduction in UI frequency in Group A will be clinically meaningful as measured by a corresponding improvement on questionnaires of satisfaction and quality of life as well as a decline in other urinary symptoms including urgency and nocturia.
Interventions
- BEHAVIORAL Exercise-based behavioral therapy
- BEHAVIORAL Behavioral control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-08 |
| Phase | Phase 3 |
What the finished NCT01520948 record still lists
NCT01520948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Exercise-based behavioral therapy is the first listed.
NCT01520948 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01520948 about?
NCT01520948 is a clinical study titled "Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease". Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI), urgency, and/or nocturia, are...
What is the current status of trial NCT01520948?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2012-09. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01520948?
The interventions under investigation include: Exercise-based behavioral therapy (BEHAVIORAL), Behavioral control (BEHAVIORAL).
Who is sponsoring clinical trial NCT01520948?
This trial is sponsored by Atlanta VA Medical Center, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01520948's enrollment target sits among peer trials
53 1839th of 2000 higher than 160 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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