Behavioral sleep intervention for urinary incontinence in older women
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
This study is testing whether improving sleep can help older women with urgency urinary incontinence feel better and have more control over their bladder.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05604222 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a behavioral sleep intervention combined with standard pharmacotherapy on urgency urinary incontinence (UUI) in older women. It aims to explore how improving sleep can enhance bladder control and the brain mechanisms involved in continence. The study will evaluate brain changes associated with sleep treatment and its effects on lower urinary tract symptoms, particularly nocturia. By addressing both bladder and sleep issues, the researchers hope to improve treatment outcomes for this prevalent condition.
Who should consider this trial
Good fit: Ideal candidates for this study are ambulatory women aged 60 and older who experience urgency urinary incontinence and nocturia at least twice a night.
Not a fit: Patients with cognitive impairments or contraindications to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for older women suffering from urinary incontinence by enhancing bladder control through better sleep.
How similar studies have performed: While the relationship between sleep and bladder control is recognized, this specific approach of combining sleep intervention with pharmacotherapy has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Shachi Tyagi, MD — University of Pittsburgh
- Study coordinator: Shachi Tyagi, MD
- Email: tyagis@upmc.edu
- Phone: 412-647-1274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.