Early phase 1CompletedAge-related condition
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study
- Sponsor
- The University of Texas Medical Branch, Galveston (Academic or other)
- Enrollment
- 48 enrolled
- Conditions
- Urinary Bladder, Overactive; Urinary Incontinence; Accidental Falls
- Interventions
- Pelvic Floor Muscle Training; Mirabegron; Trospium Chloride
- Ages
- adults, older adults
- Registry
- NCT05880862
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Evaluability
- Clinical-Based Adherence
- Home-Based Adherence
- Medication Adherence
History
Last registry update
Primary completion
Started
Registered