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Sleep training plus bladder pill may cut nighttime bathroom trips in older women
NCT ID NCT05604222
First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This study looks at whether adding a brief sleep program to standard bladder medication can reduce urgent leaks and nighttime urination in women aged 60 and older. About 120 women with frequent urgency incontinence and nocturia will receive either medication alone or medication plus a behavioral sleep intervention. The goal is to see if improving sleep helps bladder control and to understand brain changes involved.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mirabegron (Myrbetriq) and Brief Behavioral Treatment for Insomnia
- What this could lead to
- If successful, this could show that treating poor sleep alongside standard medication reduces bladder leaks and nighttime bathroom trips in older women.
- What could go wrong
- This is a small, early-phase study with only 120 participants, so results may not apply to everyone. The sleep intervention requires active participation and may not work for all.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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60 years and older
- Sex
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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 Hide 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: * ambulatory women aged 60+ years * urgency incontinence or urge-predominant mixed incontinence (able to differentiate between stress symptoms-cough, laugh, exercise-and leakage following the sudden onset of a strong urge to void that is difficult to defer during questioning on telephone screening) occurring at least five times weekly for ≥ 3 months despite treatment for reversible causes * nocturia ≥2 each night * subjects with current or previous use of anticholinergic medications will be considered for the study if willing to go through a washout period of at least 4 weeks of duration Exclusion Criteria: * contraindication to any of the drugs used (e.g., mirabegron, prophylactic antibiotics) * cognitive impairment (MOCA score \<24 or inability to accurately complete a voiding diary, perform a 24-hour pad test, reliably take daily medication, or comply with fMRI testing) * prior treatment with intradetrusor onabotulinum toxin or sacral neuromodulation. * spinal cord injury; history of pelvic irradiation, advanced uterine or bladder cancer; multiple sclerosis * urethral obstruction; urinary retention \[PVR \>200 ml\] * interstitial cystitis; artificial sphincter implant * medical instability or expected change in medication during the study * conditions that preclude fMRI testing, such as history of claustrophobia, history or suspicion of implanted metal or electronic object * requirement for intravenous antibiotics for bacterial endocarditis prophylaxis or presence of multiple allergies to the antibiotics available in our protocol * chronic or recurrent bowel issues, e.g. IBS, colitis, fecal incontinence * known allergy to study medication or interaction with current medications * severe uncontrolled hypertension \>180 mmHg systolic or \>100 mmHg diastolic
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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