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Can pelvic floor training beat pills for bladder leaks in seniors?

NCT ID NCT05880862

Symptom relief Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether pelvic floor muscle training, mirabegron, or trospium chloride is better for treating urgency urinary incontinence in women aged 60 and older who are also at high risk of falling. 48 women were randomly assigned to one of three groups and followed for six months. The goal was to see if a larger trial is possible and how each treatment affects bladder symptoms and fall risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pelvic floor muscle training, mirabegron, trospium chloride
What this could lead to
If successful, this could show which treatment works best for bladder control in older women who are also at risk of falling, potentially guiding safer care.
What could go wrong
This is a very early feasibility study with only 48 participants, so results may not apply to all women. The treatments may not improve symptoms or fall risk as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

48 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women aged 60 year or older. 2. Ambulatory (able to walk across a small room with or without an assistive device). 3. Urgency UI, OAB, or Mixed UI (both urgency and stress UI) as identified by study physicians. 4. Answered "yes" to one of the items on the 3-Key Questions, questionnaire. 5. A score of 6 or greater on the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB) instrument or a physician recommended treatment. 6. Able to provide one's own informed consent. 7. Has tried basic lifestyle modifications for her bladder condition. 8. Has Medicare or private insurance Exclusion Criteria: 1. Male (their causes of urinary incontinence are often different from women) 2. Unstable psychiatric conditions (e.g., psychosis, suicidal) based on history and medical records. 3. Nursing home resident 4. Genitourinary cancer undergoing active treatment with chemotherapy or radiation. 5. Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, Traumatic Brain Injury, Dementia, and Stroke Survivors with limited mobility) 6. New OAB treatments planned during the 6-month study duration - includes medications and/or surgery. 7. History of surgically implanted sacral nerve stimulator or botulinum toxin bladder injections for UI. 8. Taking other antimuscarinic drugs or Digoxin 9. Severe uncontrolled hypertension 10. Diagnosed Glaucoma 11. Myasthenia gravis 12. Chronic liver or kidney diseases

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Accidental falls Urinary bladder, overactive Urinary incontinence

Contacts and locations

Locations

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.