RECRUITING

Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

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

This is a randomized double-blind crossover trial of trospium and placebo in women with urgency urinary incontinence, with evaluation (history, physical, incontinence evaluation and brain MRI) at baseline, and after each course of therapy. The investigators will evaluate functional brain changes in relation to bladder improvement in order to improve our knowledge of the brain's role in the continence mechanism.

Official Title

Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

Quick Facts

Study Start:2020-02-13
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04227184

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:60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 60+ years old
  2. 2. Has UUI or urge-predominant mixed incontinence at least 5 times/ week for \> 3 months despite treatment for reversible causes
  1. 1. conditions/medications contraindicating trospium
  2. 2. If currently taking anticholinergic medications (participant must refrain from anticholinergic medications for 4 weeks prior enrollment in order to be eligible)
  3. 3. Impaired mobility or cognition sufficient to preclude following study procedures; MoCA test score \<24/30; a clinically-apparent neurological condition
  4. 4. Prolapse beyond the hymen
  5. 5. Interstitial cystitis
  6. 6. Spinal cord injury
  7. 7. History of pelvic radiation or advanced uterine/bladder cancer
  8. 8. Urethral obstruction (uroflow); PVR \>200 ml
  9. 9. Medical instability
  10. 10. Prior UUI treatment with onabotulinum toxin or neuromodulation
  11. 11. Drug interaction or expected medication change during the study
  12. 12. Conditions requiring IV antibacterial prophylaxis
  13. 13. New incontinence treatment \< 3 months prior to enrollment
  14. 14. Fecal incontinence, and symptomatic colitis/IBS
  15. 15. Contraindications to MRI.

Contacts and Locations

Study Contact

Becky Clarkson, PhD
CONTACT
412-647-1270
bdc29@pitt.edu

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: Becky Clarkson

  • 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 Date2020-02-13
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2020-02-13
Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

  • Urinary Incontinence
  • Urgency urinary incontinence
  • Trospium

Additional Relevant MeSH Terms

  • Urgency Urinary Incontinence