NCT05604222
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
Active, Not Recruiting
PHASE4Ages 60+InterventionalTreatmentShachi TyagiInvestigator-initiated
~120 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Mirabegron 50 MGBrief Behavioral Treatment for Insomnia
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incontinence episodes
Measured over Baseline to 8 weeks
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Shachi Tyagi, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Incontinence episodesBaseline to 8 weeks
The number of incontinence episodes