ACTIVE_NOT_RECRUITING

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

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Conditions

Urgency Urinary IncontinenceUrinary Incontinence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-14
Study Completion:2026-01-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04599088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 'Old' (community-dwelling, mentally and functionally intact ambulatory women aged 65+ years) or 'Young' (equivalent women aged 18-45)
  2. * '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.
  3. * 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.
  4. * 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.
  1. * Current or prior treatment for UUI
  2. * Leakage on bladder diary not ascribed to minimal SUI (see bullet above)
  3. * Cognitive impairment:
  4. * MoCA\<26
  5. * inability to perform a voiding diary/pad test
  6. * inability to reliably take daily medication
  7. * inability to comply with fMRI testing
  8. * Impaired mobility
  9. * Medical instability:
  10. * severe uncontrolled hypertension \>180mmHg systolic or \>100mmHg diastolic
  11. * potential major changes in medical management over the course of the study period (i.e. upcoming surgery/treatment)
  12. * frailty according to the Fried criteria
  13. * MRI incompatibility:
  14. * contraindicated metal implants
  15. * claustrophobia
  16. * unidentified/untested compatibility of metal implants
  17. * Medication incompatibility:
  18. * allergy to study medication (all prophylactic antibiotic choices)
  19. * interaction of prophylactic antibiotic choices with current medications
  20. * expected change in medication during the study
  21. * Neurological conditions:
  22. * spinal cord injury;
  23. * multiple sclerosis
  24. * clinically apparent lesions (e.g. lacunae associated with stroke)
  25. * prior stroke
  26. * Parkinson's Disease/ALS/MSA
  27. * any clinically apparent neurological condition
  28. * Lower urinary tract comorbidities/treatment:
  29. * history of pelvic irradiation
  30. * bladder or advanced uterine cancer
  31. * possible urethral obstruction (advanced prolapse \[POP-Q\>II\] or Qmax\<12 ml/s on free flow)
  32. * urinary retention (PVR \>200 ml)
  33. * Interstitial Cystitis/Bladder Pain Syndrome
  34. * artificial sphincter implant
  35. * Botox treatment for UUI within 1 year
  36. * Neuromodulation treatment for UUI
  37. * Other comorbidities:
  38. * uncontrolled depression (PHQ-9 ≥10)

Contacts and Locations

Principal Investigator

Becky Clarkson, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Becky Clarkson, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-14
Study Completion Date2026-01-03

Study Record Updates

Study Start Date2020-12-14
Study Completion Date2026-01-03

Terms related to this study

Keywords Provided by Researchers

  • Urinary Incontinence
  • Urgency urinary incontinence

Additional Relevant MeSH Terms

  • Urgency Urinary Incontinence