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

Mackay Memorial Hospital

Status and phase: Enrolling; Phase 4

Conditions: Urinary Bladder, Overactive; Effect of Drug

Treatments: Drug: Combined pharmacotherapy with Solifenacin and Mirabegron; Drug: Mirabegron with vaginal estrogen cream; Drug: Solifenacin with vaginal estrogen cream

Study type: Interventional

Funder types: Other

Identifiers

NCT06479720

22MMHIS039e-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 3 patient groups

Solifenacin and mirabegron

Active Comparator group

Description:

Solifenacin 5mg and Mirabegron 25mg

Treatment:

Drug: Combined pharmacotherapy with Solifenacin and Mirabegron

Solifenacin with vaginal estrogen cream

Experimental group

Description:

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

Treatment:

Drug: Solifenacin with vaginal estrogen cream

Mirabegron with vaginal estrogen cream

Experimental group

Description:

Mirabegron 25mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.

Treatment:

Drug: Mirabegron with vaginal estrogen cream