Investigating brain mechanisms in urgency urinary incontinence
Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence
This study is testing whether a medication called trospium can help older women with urgency urinary incontinence feel better and if it affects their brain function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04227184 on ClinicalTrials.gov |
What this trial studies
This randomized double-blind crossover trial evaluates the effects of trospium versus placebo in women aged 60 and older with urgency urinary incontinence (UUI). Participants will undergo assessments including medical history, physical examinations, incontinence evaluations, and brain MRI scans at baseline and after each treatment phase. The study aims to understand the functional brain changes associated with bladder improvement, potentially leading to new treatment strategies for UUI. By exploring the brain's role in continence mechanisms, the research seeks to enhance current therapeutic approaches.
Who should consider this trial
Good fit: Ideal candidates are women aged 60 and older who experience urgency urinary incontinence at least five times a week for more than three months.
Not a fit: Patients with conditions contraindicating trospium or those currently taking anticholinergic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for urgency urinary incontinence, improving patients' quality of life.
How similar studies have performed: While some studies have explored brain mechanisms in bladder control, this specific approach using trospium is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Becky Clarkson, PhD — University of Pittsburgh
- Study coordinator: Becky Clarkson, PhD
- Email: bdc29@pitt.edu
- Phone: 412-647-1270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.