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NCT05880862 · ClinicalTrials.gov registry record · Early Phase 1
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
A Early Phase 1 study of Urinary Incontinence and Accidental Falls, sponsored by The University of Texas Medical Branch, Galveston.
- Active
- Registry status
- Early Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT05880862: Active Early Phase 1 study of Urinary Incontinence and Accidental Falls, sponsored by The University of Texas Medical Branch, Galveston.
NCT05880862 is a Early Phase 1 study of Urinary Incontinence and Accidental Falls that is active but no longer recruiting, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 48 participants, below the 261-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05880862, a Early Phase 1 study of Urinary Incontinence and Accidental Falls, is active but no longer recruiting, sponsored by The University of Texas Medical Branch, Galveston.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to conduct a randomized pilot multi-arm clinical trial comparing a standard course of physical therapist provided pelvic floor muscle training (PFMT) to pharmacologic therapy for the treatment of urgency urinary incontinence (UUI) or Overactive Bladder (OAB) in older women at high risk of falling. The central hypotheses for this project are i) a randomized pilot multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling is feasible; and ii) treatment approach can influence both UI and fall related outcomes in this patient population. The main questions it aims to answer are: 1) Is a multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling feasible? and 2) How does treatment approach influence both OAB and fall related outcomes in this patient population? Women (16 per arm) 60 years and older with UUI or OAB who screen positive for high fall risk will be randomized to one of three standard of care treatment arms and followed for six months. The three treatment arms are i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the outpatient physical therapy clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride. Researchers will compare study feasibility and OAB symptom related outcomes across the three groups to see if a larger clinical trial is warranted.
Primary Outcome
Number of participants completing the baseline and the post-intervention assessments divided by number enrolled.
Conditions Studied
Interventions
- DRUG Mirabegron
- BEHAVIORAL Pelvic Floor Muscle Training
- DRUG Trospium Chloride
Study Locations (1)
Texas
- University of Texas Medical Branch at Galveston - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-09-28 |
| Est. Completion | 2025-12 |
| Phase | Early Phase 1 |
What the registry record for NCT05880862 still lists
NCT05880862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 261-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Urinary Incontinence appearing as the primary indexed condition, and to 3 interventions - of which Mirabegron is the first listed.
NCT05880862 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05880862 about?
NCT05880862 is a clinical study titled "Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls". The goal of this study is to conduct a randomized pilot multi-arm clinical trial comparing a standard course of physical therapist provided pelvic floor muscle training (PFMT) to pharmacologic therapy for the treatment of urgency urinary incontinence (UUI) or Overactive Bladder (OAB) in older women ...
What is the current status of trial NCT05880862?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 48 participants. The study started on 2023-09-28. Estimated completion is 2025-12.
What conditions does trial NCT05880862 study?
This clinical trial studies the following conditions: Urinary Incontinence, Accidental Falls, Urinary Bladder, Overactive.
What interventions are being tested in trial NCT05880862?
The interventions under investigation include: Mirabegron (DRUG), Pelvic Floor Muscle Training (BEHAVIORAL), Trospium Chloride (DRUG).
Who is sponsoring clinical trial NCT05880862?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05880862 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05880862's enrollment target sits among peer trials
48 33rd of 48 higher than 16 of 48 other Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Incontinence 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.
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