NCT06197295

Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity

Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.

Detailed description

Women with detrusor overactivity who were refractory to anti-muscarinics were enrolled for prospective study. Patients were divided into two groups: one receive combined pharmacotherapy with solifenacin and mirabegron, and the other received solifenacin and vaginal estrogen cream. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in episodes of daily micturition, urgency, urinary incontinence and nocturia.

Conditions

• Urinary Bladder, Overactive
• Effect of Drug

Interventions

Type	Name	Description
DRUG	Solifenacin with vaginal estrogen cream	Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg
DRUG	Combination pharmacotherapy	Solifenacin 5mg and Mirabegron 25mg

Timeline

• Start date: 2022-06-16
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-01-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study