Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder

Phase 4

Recruiting

• Conditions: Urinary Bladder, Overactive; Effect of Drug
• Interventions: Drug: Combined pharmacotherapy with Solifenacin and Mirabegron; Drug: Solifenacin with vaginal estrogen cream; Drug: Mirabegron with vaginal estrogen cream

• Registration Number: NCT06479720
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder

Detailed Description

Women with detrusor overactivity who were refractory to anti-muscarinics or mirabegron were enrolled for prospective study. Patients were divided into three groups: combined pharmacotherapy with solifenacin and mirabegron, solifenacin with vaginal estrogen cream and mirabegron with 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.

Study Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-23
• Study First Posted: 2024-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with anti-muscarinics were enrolled for prospective study.

Exclusion Criteria

• Postvoid urine retention before treatment
• Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension
• Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solifenacin and mirabegron	Combined pharmacotherapy with Solifenacin and Mirabegron	Solifenacin 5mg and Mirabegron 25mg
Solifenacin with vaginal estrogen cream	Solifenacin with vaginal estrogen cream	Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.
Mirabegron with vaginal estrogen cream	Mirabegron with vaginal estrogen cream	Mirabegron 25mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.

Primary Outcome Measures

Name	Time	Method
Short form of Urinary Distress Inventory (UDI-6)	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment	UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence.
Overactive Bladder Symptom Score (OABSS)	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment	The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms.
Short form of Incontinence Impact Questionnaire (IIQ-7)	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment	The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships \& emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence.

Secondary Outcome Measures

Name	Time	Method
Episodes of daily urgency	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment	Patients report daily lower urinary tract symptoms episodes
Episodes of daily nocturia	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment	Patients report daily lower urinary tract symptoms episodes
Episodes of daily micturition	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment	Patients report daily lower urinary tract symptoms episodes
Episodes of daily incontinence	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment	Patients report daily lower urinary tract symptoms episodes

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan