Investigation of Brain Mechanisms Involved in the Urinary Continence Mechanism Associated With Aging

Launched by UNIVERSITY OF PITTSBURGH · Oct 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how the brain controls bladder function, specifically focusing on a common issue called urgency urinary incontinence (UUI) in older women. UUI is when a person feels a sudden, strong urge to urinate and may leak urine if they can't get to the bathroom in time. Researchers want to understand how this brain control changes with age and illness, which could help pave the way for better treatments in the future.

To participate in the study, women aged 65 and older who experience UUI more than five times a week are eligible, as well as younger women aged 18 to 45 who do not have any bladder issues. Participants will undergo tests that involve monitoring their bladder control and brain activity through imaging. It’s important to note that those with certain conditions, like cognitive impairments or severe health issues, may not be able to join the study. This research aims to improve our understanding of bladder control and ultimately enhance the quality of life for those affected by UUI.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 'Old' (community-dwelling, mentally and functionally intact ambulatory women aged 65+ years) or 'Young' (equivalent women aged 18-45)
• • 'Wet' (those who meet the International Continence Society definition of urgency urinary incontinence (urinary leakage accompanied by a sudden, strong urge to void which is difficult to defer) \>5 times per week, for 3 months despite treatment for reversible causes (e.g., Urinary tract infection) and confirmed by a mean of one episode per day of UUI on 3-day bladder diary) or 'Dry' (women without current or past UUI or other lower urinary tract symptoms.) Infrequent stress incontinence of a small amount is acceptable.
• • Urge-predominant mixed incontinence is acceptable provided the subject is able to differentiate between stress incontinence (SUI - leakage that coincides instantaneously with cough, laugh, exercise) and urgency incontinence, i.e., leakage accompanied by a sudden strong urge to void that is difficult to defer.
• • Those with current or previous use of anticholinergic/beta-3 agonist medications will be considered for the study if they are willing to go through a washout period of at least 4 weeks of duration.
• Exclusion Criteria:
• • Dry Groups
• • Current or prior treatment for UUI
• • Leakage on bladder diary not ascribed to minimal SUI (see bullet above)
• • All Groups: 'Wet' or 'Dry'; 'Young' or 'Old'
• * Cognitive impairment:
• • MoCA\<26
• • inability to perform a voiding diary/pad test
• • inability to reliably take daily medication
• • inability to comply with fMRI testing
• • Impaired mobility
• • o Timed up and go test ≥ 12 secs
• * Medical instability:
• • severe uncontrolled hypertension \>180mmHg systolic or \>100mmHg diastolic
• • potential major changes in medical management over the course of the study period (i.e. upcoming surgery/treatment)
• • frailty according to the Fried criteria
• * MRI incompatibility:
• • contraindicated metal implants
• • claustrophobia
• • unidentified/untested compatibility of metal implants
• * Medication incompatibility:
• • allergy to study medication (all prophylactic antibiotic choices)
• • interaction of prophylactic antibiotic choices with current medications
• • expected change in medication during the study
• * Neurological conditions:
• • spinal cord injury;
• • multiple sclerosis
• • clinically apparent lesions (e.g. lacunae associated with stroke)
• • prior stroke
• • Parkinson's Disease/ALS/MSA
• • any clinically apparent neurological condition
• * Lower urinary tract comorbidities/treatment:
• • history of pelvic irradiation
• • bladder or advanced uterine cancer
• • possible urethral obstruction (advanced prolapse \[POP-Q\>II\] or Qmax\<12 ml/s on free flow)
• • urinary retention (PVR \>200 ml)
• • Interstitial Cystitis/Bladder Pain Syndrome
• • artificial sphincter implant
• • Botox treatment for UUI within 1 year
• • Neuromodulation treatment for UUI
• * Other comorbidities:
• • uncontrolled depression (PHQ-9 ≥10)