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ACTIVE NOT RECRUITING

NCT04599088

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

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

Summary

Urge urinary incontinence (UUI) is a common problem in older people which vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will characterize brain control of the bladder in young and old continent individuals and age-matched incontinent counterparts. This will expand the investigators current knowledge of how the brain controls the bladder, how that control changes with age and disease, and suggest new targets to guide development of better treatment.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

207

Start Date

2020-12-14

Completion Date

2026-04-01

Last Updated

2026-02-17

Healthy Volunteers

Yes

Conditions

Urgency Urinary Incontinence

Interventions

OTHER

Brain functional MRI with simplified urodynamics

Structural: MPRAGE provides a structural image, which is used for coregistration of subjects. Structural scans are then performed including Diffusion Spectrum Imaging (DSI; microstructural), and Fluid-attenuated inversion recovery (FLAIR; white matter specific) scans. Functional: With about 50 ml in the bladder, resting state functional BOLD measurements are made, followed by functional whole-brain images while a small amount of saline is infused and withdrawn from the bladder, in 2 blocks of 4 repetitions each. Each repetition starts with a 12-scan pause, followed by infusion (6 scans = 12 s), pause (6 scans), and withdrawal (6 scans). Each block of 4 repetitions is completed by a 6 scan pause during which scanning continues. 24 ml is infused at 120 ml/min, and slightly less is withdrawn to avoid accommodation.This is repeated on an empty and full bladder along with a resting state image.

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)

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States