Understanding how aging affects bladder control in women

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

This study is trying to understand how aging affects bladder control in older women, especially those who struggle with urgency urinary incontinence, by looking at brain function and structure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Pittsburgh (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT04599088 on ClinicalTrials.gov

What this trial studies

This study investigates the brain mechanisms involved in urinary continence, particularly focusing on urgency urinary incontinence (UUI) in older women. By comparing brain function and structure between young and old women, both with and without UUI, the researchers aim to identify how bladder control changes with age. The study employs advanced neuroimaging techniques alongside simplified urodynamics to gather detailed data on brain activity related to bladder control. The findings could lead to new treatment targets for improving bladder function in older adults.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-45 or 65 and older, either with urgency urinary incontinence or without any urinary symptoms.

Not a fit: Patients with severe cognitive impairments or those unable to participate in neuroimaging procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved treatments for urgency urinary incontinence, enhancing the quality of life for older women.

How similar studies have performed: While there is emerging research on brain mechanisms related to bladder control, this specific investigation into aging and UUI is relatively novel.

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)

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Becky Clarkson, PhD — University of Pittsburgh
• Study coordinator: Becky Clarkson, PhD

Conditions: Urgency Urinary Incontinence, Urinary Incontinence, Urgency urinary incontinence