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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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

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Urinary Bladder, Overactive Effect of Drug

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Solifenacin with vaginal estrogen cream

Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.

Group Type EXPERIMENTAL

Solifenacin with vaginal estrogen cream

Intervention Type DRUG

Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg

Combination pharmacotherapy

Combined solifenacin 5mg and mirabegron 25mg once per day.

Group Type ACTIVE_COMPARATOR

Combination pharmacotherapy

Intervention Type DRUG

Solifenacin 5mg and Mirabegron 25mg

Interventions

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Solifenacin with vaginal estrogen cream

Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg

Intervention Type DRUG

Combination pharmacotherapy

Solifenacin 5mg and Mirabegron 25mg

Intervention Type DRUG

Other Intervention Names

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Premarin Vesicare and Betmiga

Eligibility Criteria

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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.
* Women who were on hormone replacement therapy within 3 months were also excluded from the study

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No