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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Shachi Tyagi, MD
tyagis@upmc.edu
412-647-1274
Time Frame
Start Date: 2023-03-05
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 120
Treatments
Experimental: Mirabegron
Mirabegron for 8 weeks
Experimental: Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)
Mirabegron for 8 weeks and a 4 week behavioral intervention for insomnia
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Shachi Tyagi

This content was sourced from clinicaltrials.gov