Actively Recruiting
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
Led by Shachi Tyagi · Updated on 2026-05-08
120
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
S
Shachi Tyagi
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ambulatory women aged 60 years or older
- Urgency incontinence or urge-predominant mixed incontinence occurring at least five times weekly for 3 months or more despite treatment for reversible causes
- Nocturia of 2 or more times each night
- Willingness to undergo a washout period of at least 4 weeks if currently or previously using anticholinergic medications
You will not qualify if you...
- Contraindication to study drugs such as mirabegron or prophylactic antibiotics
- Cognitive impairment indicated by MOCA score less than 24 or inability to complete study tasks
- Prior treatment with intradetrusor onabotulinum toxin or sacral neuromodulation
- Spinal cord injury, history of pelvic irradiation, advanced uterine or bladder cancer, or multiple sclerosis
- Urethral obstruction or urinary retention with post-void residual over 200 ml
- Interstitial cystitis or artificial sphincter implant
- Medical instability or expected change in medication during the study
- Conditions preventing fMRI testing such as claustrophobia or implanted metal/electronic devices
- Need for intravenous antibiotics for bacterial endocarditis prophylaxis or multiple antibiotic allergies
- Chronic or recurrent bowel issues like IBS, colitis, or fecal incontinence
- Known allergy to study medication or interactions with current drugs
- Severe uncontrolled hypertension with systolic over 180 mmHg or diastolic over 100 mmHg
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Shachi Tyagi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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