Phase 4
N=168
Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence
Urgency Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT04227184 ↗Enrolled (actual)
168
Serious AEs
3.5%
Results posted
Apr 2026
Primary outcome: Primary: Responder (Yes/no) — 23; 39; 36; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trospium (Drug); Placebo oral tablet (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- Becky Clarkson
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder (Yes/no) |
23; 39; 36; 17 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 60+ years old
- Has UUI or urge-predominant mixed incontinence at least 5 times/ week for > 3 months despite treatment for reversible causes
Exclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT04227184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.