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Urinary Bladder, OveractiveEarly Phase 1NCT05880862

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

A Early Phase 1 study testing Pelvic Floor Muscle Training, Mirabegron and Trospium Chloride in people with Urinary Bladder, Overactive and Urinary Incontinence, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 99 years, women only
What is being tested?
Pelvic Floor Muscle Training, Mirabegron and Trospium Chloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
28 Sep 2023to 27 Dec 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

Other trials in United States

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

Untreated, urinary urgency and incontinence can precipitate a vicious cycle of decreasing physical activity, social isolation, fear-of-falling, and falls. The urge to urinate frequently can also limit physical activity - concern for finding oneself too far from a bathroom can be a powerful motivator for just staying home. Structured behavioral interventions or medications are common initial treatment options. But they elicit their effects through very different mechanisms of action that may influence fall related outcomes differently. There is, however, a critical lack of direct head-to-head trial evidence on non-pharmacologic and pharmacologic treatments for urgency urinary incontinence (UUI), particularly in women with co-existing fall risk. The proposed feasibility pilot study is a randomized, multi-arm, mixed methods, clinical trial comparing three currently in use initial treatment options for older women: 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, in women 60 and older with UUI or overactive bladder (OAB) who also screen positive for increased risk of falling. Mirabegron and Trospium are not associated with longitudinal effects on cognition that the traditionally used anticholinergic mediations have recently been linked to. The Specific Aims are 1) Conduct a pilot study in clinical settings to determine the feasibility of enrolling older women with UUI or OAB who are at high risk of falling in a three-arm (PFMT, vs. mirabegron vs. Trospium), randomized comparative effectiveness trial; 2) Characterize outcomes across the three interventions; and 3) Qualitatively explore perceived factors influencing the non-pharmacologic and pharmacologic treatment experience in these patients. Forty-eight ambulatory women (16 per arm) 60 years and older with UUI or OAB and who screen positive for high fall risk will be randomized (1:1:1) to one of three arms. Feasibility will be determined through key milestones on evaluability, adherence to the interventions, attrition, adverse events, productive recruitment methods, and sample characteristics. The Investigators will also measure important indicators of symptom severity, quality of life, physical activity, falls, and fear of falling. Building upon our preliminary work, fall risk will be determined by the Centers for Disease Control and Prevention (CDC), Stopping Elderly Accidents, Deaths, and Injuries (STEADI) fall risk screening tool. The proposed study is the first to compare these common non-surgical treatments for UUI and OAB in a high fall risk patient population and will lay the groundwork for a program of research investigating the bidirectional relationships that exist across these two common geriatric syndromes both at the level of shared risk factors and response to treatment.

Being tested
Pelvic Floor Muscle Training, Mirabegron, Trospium Chloride
Keywords
OAB, Falls, Older adults, Urinary incontinence
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic Floor Muscle TrainingBehavioural

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

  • MirabegronDrug

    Also called Myrbetriq

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

  • Trospium ChlorideDrug

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

Study groups in NCT05880862
Study groupRoleWhat they receive
Pelvic Floor Muscle TrainingExperimentalA 12-week, 6 visit, outpatient program of physical therapist delivered behavioral and pelvic floor muscle training (PFMT)
Receives: Behavioral: Pelvic Floor Muscle Training
MirabegronActive comparatorIndividually titrated Mirabegron, starting at 25 mg daily and increased to 50 mg daily at 6-weeks, during the 12-week intervention period.
Receives: Drug: Mirabegron
Trospium ChlorideActive comparatorA 12-week course of Trospium -extended release, 60mg once daily.
Receives: Drug: Trospium Chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluability

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

    Measured: Assessed at the end of the 12-week intervention period

  2. 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.

    Measured: Assessed at the end of the 12-week intervention period

  3. 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.

    Measured: Assessed at the end of the 12-week intervention period

  4. Medication Adherence

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

    Measured: Assessed at the end of the 12-week intervention period

Secondary outcomes (9)

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

    The ICIQ-OAB is a patient reported outcome that captures self-perceived degree of urinary frequency, urinary urgency (rushing to the bathroom), and urge incontinence (leakage) as well as symptoms related to nocturia (nighttime urination). The overall score is 0-16 with greater values indicating increased symptom severity.

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

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

    The ICIQ-LUTSqol measures the influence of urinary incontinence problems on the quality of life, and changes in interpersonal relations in everyday life. The overall score of ICIQ-LUTSqol is 19-76 score with greater values indicating increased impact on quality of life.

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

  3. Falls Efficacy Scale International (FES-I)

    The Falls Efficacy Scale International (FES-I) is a patient reported outcome that measures level of concern about falling during daily activities inside and outside the home whether or not she actually does the activity. FES-I score ranges from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

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

  4. Number of Participants with Incident falls

    An event which results in a person coming to rest inadvertently on the ground or floor or other lower level.

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

  5. PROMIS Satisfaction with Participation in Social Roles

    PROMIS self-reported questionnaire that measures the general satisfaction with performing one's usual social roles and activities. For the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. A higher score equals higher physical functioning.

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

  6. Short Physical Performance Battery (SPPB)

    A battery of 3 physical performance tests: 1) the ability to stand with the feet together in side-by-side, semi-tandem, and tandem positions; 2) time to walk 3 meters; and 3) time to rise from a chair 5 times. A rank ordinal score is given for each test, then all 3 are summed. SPPB total scores range from 0 (worst performance) to 12 (best performance).

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

  7. Physical activity

    Physical activity monitoring via accelerometry will be used to assess sedentary and physical activity behaviors by calculating total number of steps taken per complete 24 hour day (i.e., midnight-to-midnight) during each monitoring period.

    Measured: The accelerometer will be worn for 1 week after randomization; for 1 week at the end of the 12-week intervention; and for 1 week at the 6-month follow-up.

  8. PROMIS physical functioning 8b

    PROMIS physical function questionnaire assesses self-reported capability rather than actual performance. This includes functioning of upper \& lower extremities, mobility, as well as instrumental activities of daily living, such as running errands. For the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. A higher score equals higher physical functioning.

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

  9. Absorbent pad use

    Self-reported daily number of absorbent pad used in the previous week. Higher numbers of self reported daily pad use is considered worse than low numbers of daily pad use.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start28 Sep 2023
  3. Primary completion27 Dec 2025
  4. Study completion27 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a pilot, multi-arm, mixed methods, randomized clinical study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880862
Sponsor's protocol ID
22-0262
Other IDs
R21AG081900
Status last verified
Jun 2026
First submitted
5 May 2023
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10894308

  • 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.

    PubMed 19463079

  • 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.

    PubMed 21948857

  • 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/

    PubMed 30516945

  • 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.

    PubMed 28471525

  • 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.

    PubMed 34628446

  • 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.

    PubMed 38178267

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pelvic Floor Muscle Training, Mirabegron and Trospium Chloride in people with Urinary Bladder, Overactive and Urinary Incontinence, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluability (time frame: Assessed at the end of the 12-week intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880862, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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