Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Urgency urinary incontinence (UUI) is common in older people and vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will investigate the role of adding behavioral sleep intervention to the standard pharmacotherapy in treatment of UUI among older adults, and the brain mechanisms involved in continence by evaluating brain changes. This will expand the current knowledge of how the sleep affects bladder control, and better characterize the brain mechanisms in maintaining continence.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shachi Tyagi
• Collaborator: National Institute on Aging (NIA)
• Treatments: Mirabegron

Criteria

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