Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence

NCT ID: NCT04227184

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-13
• Study Completion Date: 2025-10-30

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.

Conditions

Urgency Urinary Incontinence

Keywords

Urinary Incontinence; Urgency urinary incontinence; Trospium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Placebo/Trospium

Placebo first for 12 weeks followed by Trospium for 12 weeks.

Group Type: EXPERIMENTAL

Trospium

Intervention Type: DRUG

Drug to treat overactive bladder

Placebo oral tablet

Intervention Type: DRUG

Placebo tablet containing no active drug

Trospium/Placebo

Trospium first for 12 weeks followed by Placebo for 12 weeks

Group Type: EXPERIMENTAL

Trospium

Intervention Type: DRUG

Drug to treat overactive bladder

Placebo oral tablet

Intervention Type: DRUG

Placebo tablet containing no active drug

Interventions

Trospium

Drug to treat overactive bladder

Intervention Type: DRUG

Placebo oral tablet

Placebo tablet containing no active drug

Intervention Type: DRUG

Other Intervention Names

Sanctura; Placebo

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Becky Clarkson

OTHER

Sponsor Role: lead

Responsible Party

Becky Clarkson

Research Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Becky Clarkson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AG064251

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19090167

Identifier Type: -

Identifier Source: org_study_id