Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    220
  • sponsor
    Neil M. Resnick
Updated on 10 June 2021

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.

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.

Details
Condition Urgency Urinary Incontinence
Treatment Placebo Oral Tablet, trospium
Clinical Study IdentifierNCT04227184
SponsorNeil M. Resnick
Last Modified on10 June 2021

Eligibility

Yes No Not Sure

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 <24/30; a clinically-apparent neurological condition
Prolapse beyond the hymen
Interstitial cystitis
Spinal cord injury
History of pelvic radiation or advanced uterine/bladder cancer
Urethral obstruction (uroflow); PVR >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
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