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

NCT05604222 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-15

No results posted yet for this study

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

Interventions

DRUG

Mirabegron 50 MG

Medication to treat overactive bladder

BEHAVIORAL

Brief Behavioral Treatment for Insomnia

A behavioral intervention for insomnia

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Shachi Tyagi

    lead OTHER

Principal Investigators

  • Shachi Tyagi, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-05
Primary Completion
2026-06-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604222 on ClinicalTrials.gov