Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

NCT04227184 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: STUDY19090167R01AG064251
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Urinary Incontinence; Urgency urinary incontinence; Trospium

Outcome Measures

Primary Outcomes (1)

• Responder (Yes/no)

  Whether reduction in number of leaks on 3-day bladder diary is at least 50%

  Baseline to 12 weeks and baseline to 24 weeks

Study Arms (2)

Placebo/Trospium

EXPERIMENTAL

Placebo first for 12 weeks followed by Trospium for 12 weeks.

Drug: Trospium; Drug: Placebo oral tablet

Trospium/Placebo

EXPERIMENTAL

Trospium first for 12 weeks followed by Placebo for 12 weeks

Drug: Trospium; Drug: Placebo oral tablet

Interventions

Trospium DRUG

Drug to treat overactive bladder

Also known as: Sanctura

Placebo/Trospium; Trospium/Placebo

Placebo oral tablet DRUG

Placebo tablet containing no active drug

Also known as: Placebo

Placebo/Trospium; Trospium/Placebo

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Potential participants must be biologically female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• Has UUI or urge-predominant mixed incontinence at least 5 times/ week for \> 3 months despite treatment for reversible causes

You may not qualify if:

• conditions/medications contraindicating trospium
• If currently taking anticholinergic medications (participant must refrain from anticholinergic medications for 4 weeks prior enrollment in order to be eligible)
• Impaired mobility or cognition sufficient to preclude following study procedures; MoCA test score \<24/30; a clinically-apparent neurological condition
• Prolapse beyond the hymen
• Interstitial cystitis
• Spinal cord injury
• History of pelvic radiation or advanced uterine/bladder cancer
• Urethral obstruction (uroflow); PVR \>200 ml
• Medical instability
• Prior UUI treatment with onabotulinum toxin or neuromodulation
• Drug interaction or expected medication change during the study
• Conditions requiring IV antibacterial prophylaxis
• New incontinence treatment \< 3 months prior to enrollment
• Fecal incontinence, and symptomatic colitis/IBS
• Contraindications to MRI.

Sponsors & Collaborators

• Becky Clarkson: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

trospium chloride

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a mechanistic study designed to use the study drug as a probe (rather than evaluate efficacy) to understand the brain's role in bladder control. We present the primary outcome of response to drug/placebo as a cross-over drug study. The synthesis of these groups allows in depth analysis of changes in brain structure and function which will provide insight into how the brain controls the bladder. However, such analysis is complex and challenging to convey in a rigid format such as this.

Results Point of Contact

• Title: Dr. Becky Clarkson
• Organization: University of Pittsburgh

bdc29@pitt.edu

4126471270

Study Officials

• Becky Clarkson, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: February 13, 2020
• Primary Completion: February 28, 2025
• Study Completion: October 30, 2025
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication, no end date
• Access Criteria: Any purpose

Locations

US (1)