Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Urgency urinary incontinence (UUI) costs the US $83 billion/year, owing in large part to its increased prevalence with age, particularly in women: 9% of those over age 18 and 36% of those over age 65. UUI also impairs quality of life, social interaction, and independence; contributes to functional decline; and increases risk for falls, hip fractures, UTIs, urosepsis, anxiety, depression, and institutionalization.The cause of UUI is unknown. Its urgency and leakage are usually ascribed to detrusor overactivity (DO, involuntary detrusor contraction), suggesting that the cause is intrinsic to the bladder even though DO is not always confirmed on testing. Because of this assumption, most therapies target the bladder albeit with only moderate success: e.g., anticholinergics reduce incontinence episodes but their benefit and tolerability (especially for older adults) are sufficiently low that 75% of patients discontinue them within a year. By contrast, therapies such as biofeedback-assisted pelvic muscle therapy (BFB) tackle behaviors. Moreover, the use of biofeedback to retrain the brain shows that the central control mechanism can be targeted and improved. Thus, the present proposal is designed to further elucidate this mechanism, thereby paving the way for discovery of new and more effective ways to control UUI. These could transform current treatment and either complement or supplant current therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04227184
Study type Interventional
Source University of Pittsburgh
Contact Becky Clarkson, PhD
Phone 412-647-1270
Email bdc29@pitt.edu
Status Recruiting
Phase Phase 4
Start date February 13, 2020
Completion date May 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT05557175 - Repetitive Transcranial Magnetic Stimulation (rTMS) on Neurogenic Overactive Bladder in Stroke N/A
Recruiting NCT05512039 - Reduced-dose Botox for Urgency Incontinence Among Elder Females Phase 1/Phase 2
Recruiting NCT05604222 - Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women Phase 4
Recruiting NCT05806164 - Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence Phase 4
Completed NCT01505439 - A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence Phase 4
Recruiting NCT04731961 - Reduction in Number of Botox Injections for Urgency Urinary Incontinence N/A
Completed NCT02833402 - Sacral Neuromodulation and the Microbiome
Recruiting NCT04599088 - Investigation of Brain Mechanisms Involved in the Urinary Continence Mechanism Associated With Aging N/A
Completed NCT03029624 - eCoin Tibial Nerve Stimulation for OAB N/A