Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

Launched by BECKY CLARKSON · Jan 9, 2020

Keywords

ClinConnect Summary

This clinical trial is looking into how certain brain functions relate to a condition called urgency urinary incontinence (UUI), where people feel a sudden, strong urge to urinate. The study involves women aged 60 and older who experience this condition at least five times a week, even after trying other treatments. Participants will take either a medication called trospium or a placebo (a non-active pill) in a randomized order, meaning some will receive the real medication first, while others will start with the placebo. Throughout the study, participants will undergo evaluations, including physical exams, bladder assessments, and brain scans (MRIs), to see how their bladder function and brain activity change.

To be eligible for the trial, women must be over 60 and have been experiencing UUI regularly for at least three months. However, there are certain conditions that would exclude someone from participating, such as specific medical issues or medications that could interfere with the study. If you choose to participate, you will have regular assessments to monitor your progress and help researchers understand how the brain contributes to bladder control. This could ultimately lead to better treatments for women suffering from UUI.

Gender

FEMALE

Eligibility 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.