Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

• Status: Recruiting
• Trial end date: 2025-05-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neil M. Resnick
• Collaborator: National Institute on Aging (NIA)
• Treatments: Trospium chloride

Criteria

Inclusion 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

Exclusion Criteria:

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.