Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

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.

Conditions

Urgency Urinary Incontinence

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Study Overview

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Study Details

Study overview

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.

Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

Condition
Urgency Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 60+ years old
  • 2. Has UUI or urge-predominant mixed incontinence at least 5 times/ week for \> 3 months despite treatment for reversible causes
  • 1. conditions/medications contraindicating trospium
  • 2. If currently taking anticholinergic medications (participant must refrain from anticholinergic medications for 4 weeks prior enrollment in order to be eligible)
  • 3. Impaired mobility or cognition sufficient to preclude following study procedures; MoCA test score \<24/30; a clinically-apparent neurological condition
  • 4. Prolapse beyond the hymen
  • 5. Interstitial cystitis
  • 6. Spinal cord injury
  • 7. History of pelvic radiation or advanced uterine/bladder cancer
  • 8. Urethral obstruction (uroflow); PVR \>200 ml
  • 9. Medical instability
  • 10. Prior UUI treatment with onabotulinum toxin or neuromodulation
  • 11. Drug interaction or expected medication change during the study
  • 12. Conditions requiring IV antibacterial prophylaxis
  • 13. New incontinence treatment \< 3 months prior to enrollment
  • 14. Fecal incontinence, and symptomatic colitis/IBS
  • 15. Contraindications to MRI.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Becky Clarkson,

Becky Clarkson, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2025-05-30