Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls

NCT05880862 | Active Not Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 22-0262R21AG081900
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Accidental Falls

Keywords

OAB; Falls; Older adults; Urinary incontinence

Outcome Measures

Primary Outcomes (4)

• Evaluability

  Number of participants completing the baseline and the post-intervention assessments divided by number enrolled.

  Assessed at the end of the 12-week intervention period

• Clinical-Based Adherence

  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.

  Assessed at the end of the 12-week intervention period

• Home-Based Adherence

  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.

  Assessed at the end of the 12-week intervention period

• Medication Adherence

  Medication arms adherence will be calculated as pill counts, i.e., number of pills dispensed minus the number of pills returned.

  Assessed at the end of the 12-week intervention period

Secondary Outcomes (9)

• International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB)

  Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.

• International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

  Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.

• Falls Efficacy Scale International (FES-I)

  Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.

• Number of Participants with Incident falls

  Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.

• PROMIS Satisfaction with Participation in Social Roles

  Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.

Other Outcomes (1)

• Qualitative interviews

  Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.

Study Arms (3)

Pelvic Floor Muscle Training

EXPERIMENTAL

A 12-week, 6 visit, outpatient program of physical therapist delivered behavioral and pelvic floor muscle training (PFMT)

Behavioral: Pelvic Floor Muscle Training

Mirabegron

ACTIVE COMPARATOR

Individually titrated Mirabegron, starting at 25 mg daily and increased to 50 mg daily at 6-weeks, during the 12-week intervention period.

Drug: Mirabegron

Trospium Chloride

ACTIVE COMPARATOR

A 12-week course of Trospium -extended release, 60mg once daily.

Drug: Trospium Chloride

Interventions

Pelvic Floor Muscle Training BEHAVIORAL

A 12-week, 6 visit, outpatient program of physical therapist delivered behavioral and pelvic floor muscle training (PFMT)

Pelvic Floor Muscle Training

Mirabegron DRUG

Individually titrated Mirabegron, starting at 25 mg daily and increased to 50 mg daily at 6-weeks, during the 12-week intervention period.

Also known as: Myrbetriq

Mirabegron

Trospium Chloride DRUG

A 12-week course of Trospium XL -extended release, 60mg once daily.

Trospium Chloride

Eligibility Criteria

• Age: 60 Years - 99 Years
• Gender Eligibility Details: The study is focused on the treatment of Overactive Bladder and Urgency Urinary Incontinence women only. The causes and treatment of these conditions in men are often different from women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 60 year or older.
• Ambulatory (able to walk across a small room with or without an assistive device).
• Urgency UI, OAB, or Mixed UI (both urgency and stress UI) as identified by study physicians.
• Answered "yes" to one of the items on the 3-Key Questions, questionnaire.
• A score of 6 or greater on the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB) instrument or a physician recommended treatment.
• Able to provide one's own informed consent.
• Has tried basic lifestyle modifications for her bladder condition.
• Has Medicare or private insurance

You may not qualify if:

• Male (their causes of urinary incontinence are often different from women)
• Unstable psychiatric conditions (e.g., psychosis, suicidal) based on history and medical records.
• Nursing home resident
• Genitourinary cancer undergoing active treatment with chemotherapy or radiation.
• Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, Traumatic Brain Injury, Dementia, and Stroke Survivors with limited mobility)
• New OAB treatments planned during the 6-month study duration - includes medications and/or surgery.
• History of surgically implanted sacral nerve stimulator or botulinum toxin bladder injections for UI.
• Taking other antimuscarinic drugs or Digoxin
• Severe uncontrolled hypertension
• Diagnosed Glaucoma
• Myasthenia gravis
• Chronic liver or kidney diseases

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Related Publications (7)

• Brown JS, Vittinghoff E, Wyman JF, Stone KL, Nevitt MC, Ensrud KE, Grady D. Urinary incontinence: does it increase risk for falls and fractures? Study of Osteoporotic Fractures Research Group. J Am Geriatr Soc. 2000 Jul;48(7):721-5. doi: 10.1111/j.1532-5415.2000.tb04744.x.

  PMID: 10894308 BACKGROUND

• Chiarelli PE, Mackenzie LA, Osmotherly PG. Urinary incontinence is associated with an increase in falls: a systematic review. Aust J Physiother. 2009;55(2):89-95. doi: 10.1016/s0004-9514(09)70038-8.

  PMID: 19463079 BACKGROUND

• Foley AL, Loharuka S, Barrett JA, Mathews R, Williams K, McGrother CW, Roe BH. Association between the Geriatric Giants of urinary incontinence and falls in older people using data from the Leicestershire MRC Incontinence Study. Age Ageing. 2012 Jan;41(1):35-40. doi: 10.1093/ageing/afr125. Epub 2011 Sep 24.

  PMID: 21948857 BACKGROUND

• Balk E, Adam GP, Kimmel H, Rofeberg V, Saeed I, Jeppson P, Trikalinos T. Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Aug. Report No.: AHRQ 18-EHC016-EFReport No.: PCORI(R) 2018-SR-03. Available from http://www.ncbi.nlm.nih.gov/books/NBK534625/

  PMID: 30516945 BACKGROUND

• Gibson W, Hunter KF, Camicioli R, Booth J, Skelton DA, Dumoulin C, Paul L, Wagg A. The association between lower urinary tract symptoms and falls: Forming a theoretical model for a research agenda. Neurourol Urodyn. 2018 Jan;37(1):501-509. doi: 10.1002/nau.23295. Epub 2017 May 4.

  PMID: 28471525 BACKGROUND

• Fisher SR, Harmouche I, Kilic GS. Prevalence and Predictors of Increased Fall Risk Among Women Presenting to an Outpatient Urogynecology and Pelvic Health Center. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):e7-e10. doi: 10.1097/SPV.0000000000001118.

  PMID: 34628446 BACKGROUND

• Fisher SR, Villasante-Tezanos A, Allen LM, Pappadis MR, Kilic G. 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. Pilot Feasibility Stud. 2024 Jan 4;10(1):1. doi: 10.1186/s40814-023-01440-w.

  PMID: 38178267 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

mirabegron; trospium chloride

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Officials

• Steve Fisher

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be blinded to ensure unbiased outcome findings.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot, multi-arm, mixed methods, randomized clinical study.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 30, 2023
• Study Start: September 28, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)