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

Last updated: May 6, 2025
Sponsor: Mackay Memorial Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Mirabegron with vaginal estrogen cream

Solifenacin with vaginal estrogen cream

Combined pharmacotherapy with Solifenacin and Mirabegron

Clinical Study ID

NCT06479720
22MMHIS039e-3
  • Ages 40-90
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with detrusor overactivity which defined as a urodynamic observationcharacterized by involuntary detrusor contractions during the filling phase. Thosewho were refractory to monotherapy with anti-muscarinics were enrolled forprospective study.

Exclusion

Exclusion Criteria:

  • Postvoid urine retention before treatment

  • Women who had medical illness and contraindication for using solifenacin andmirabegron, 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

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Mirabegron with vaginal estrogen cream
Phase: 4
Study Start date:
June 16, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Mackay Memorial Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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