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

Launched by SHACHI TYAGI · Oct 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a specific behavioral sleep intervention can help older women who experience urgency urinary incontinence (UUI), which is a sudden, strong urge to urinate that can lead to accidents. The trial aims to see if improving sleep habits, in addition to standard medication, can help manage these urinary symptoms and to understand how sleep affects bladder control by looking at changes in the brain.

To participate in this study, women aged 60 and older who have been experiencing UUI at least five times a week for the past three months and have nighttime urination (nocturia) at least twice a night may be eligible. Participants will work closely with researchers and may need to stop certain medications for a period before joining the study. Throughout the trial, participants will receive support and guidance on improving their sleep, and their progress will be monitored to see how these changes impact their bladder control. It's important to note that some health conditions and medications may prevent someone from participating, so a thorough screening will be conducted.

Gender

FEMALE

Eligibility 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