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Sleep training plus bladder pill may cut nighttime bathroom trips in older women

NCT ID NCT05604222

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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 years and older

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: * 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

More trials for these conditions

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