Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
Status:
Not yet recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
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 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.