Clinical trial NCT04227184: Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence
Official title: Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urgency Urinary Incontinence
Keywords: Urinary Incontinence
Urgency urinary incontinence
Trospium
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-01-13
Enrollment: 220
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Structural brain changes
timeFrame: Baseline to 12 weeks
measure: Structural brain changes
timeFrame: 12 to 24 weeks
measure: Functional brain changes
timeFrame: Baseline to 12 weeks
measure: Functional brain changes
timeFrame: 12 to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Becky Clarkson, PhD
role: PRINCIPAL_INVESTIGATOR
References: