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

NCT05604222 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY220500991R01AG076575-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urgency Urinary Incontinence; Nocturia

Outcome Measures

Primary Outcomes (1)

• Incontinence episodes

  The number of incontinence episodes

  Baseline to 8 weeks

Secondary Outcomes (3)

• Structural brain changes

  Baseline to 8 weeks

• Functional brain changes

  Baseline to 8 weeks

• Nocturia episodes

  Baseline to 8 weeks

Study Arms (2)

Mirabegron

EXPERIMENTAL

Mirabegron for 8 weeks

Drug: Mirabegron 50 MG

Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)

EXPERIMENTAL

Mirabegron for 8 weeks and a 4 week behavioral intervention for insomnia

Drug: Mirabegron 50 MG; Behavioral: Brief Behavioral Treatment for Insomnia

Interventions

Mirabegron 50 MG DRUG

Medication to treat overactive bladder

Also known as: Myrbetriq

Mirabegron; Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)

Brief Behavioral Treatment for Insomnia BEHAVIORAL

A behavioral intervention for insomnia

Also known as: BBTI

Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Potential participants must be biologically female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shachi Tyagi: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Nocturia

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shachi Tyagi, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shachi Tyagi, MD

CONTACT

412-647-1274; tyagis@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 3, 2022
• Study Start: March 5, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication, no end date
• Access Criteria: Any purpose

Locations

US (1)