NCT05880862

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

Active, enrolled EARLY_PHASE1 Last updated 17 November 2025

What this trial tests

EARLY_PHASE1 trial testing Pelvic Floor Muscle Training in Urinary Bladder, Overactive in 48 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 September 2023

Primary endpoint
1 December 2025

1 December 2025

Quick facts

Lead sponsor	The University of Texas Medical Branch, Galveston
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	28 September 2023
Primary completion	1 December 2025
Estimated completion	1 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Pelvic Floor Muscle Training
• Mirabegron (MIRABEGRON) — full drug profile →
• Trospium Chloride — full drug profile →

Conditions studied

• Urinary Bladder, Overactive — all drugs for Urinary Bladder, Overactive →
• Urinary Incontinence — all drugs for Urinary Incontinence →
• Accidental Falls — all drugs for Accidental Falls →

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Adults 60 to 99, female only, with Urinary Bladder, Overactive or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluability
  Time frame: Assessed at the end of the 12-week intervention period
  Number of participants completing the baseline and the post-intervention assessments divided by number enrolled.
• Clinical-Based Adherence
  Time frame: Assessed at the end of the 12-week intervention period
  Pelvic floor muscle training arm: clinic-based adherence over the 12-week intervention will be calculated by dividing the number of sessions attended by the number of scheduled sessions.
• Home-Based Adherence
  Time frame: Assessed at the end of the 12-week intervention period
  Home-based adherence will be percentage of adherence to the prescribed home program. Patients complete a home exercise diary each time they perform prescribed exercises. The diaries are taken to every clinic appointment and reviewed by the provider.
• Medication Adherence
  Time frame: Assessed at the end of the 12-week intervention period
  Medication arms adherence will be calculated as pill counts, i.e., number of pills dispensed minus the number of pills returned.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Fisher SR, Villasante-Tezanos A, Allen LM, Pappadis MR, et al · · 2024 · cited 1× · PMID 38178267 · DOI 10.1186/s40814-023-01440-w