Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

NCT04227184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-04-24

Study results available
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Summary

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.

Conditions

  • Urgency Urinary Incontinence

Interventions

DRUG

Trospium

Drug to treat overactive bladder

DRUG

Placebo oral tablet

Placebo tablet containing no active drug

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Becky Clarkson

    lead OTHER

Principal Investigators

  • Becky Clarkson, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2025-02-28
Completion
2025-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04227184 on ClinicalTrials.gov