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

M

Mackay Memorial Hospital

Status and phase

Enrolling
Phase 4

Conditions

Urinary Bladder, Overactive
Effect of Drug

Treatments

Drug: Combination pharmacotherapy
Drug: Solifenacin with vaginal estrogen cream

Study type

Interventional

Funder types

Other

Identifiers

NCT06197295
22MMHIS039e-2

Details and patient eligibility

About

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

Full 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.

Enrollment

100 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.
  • Women who were on hormone replacement therapy within 3 months were also excluded from the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

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
Combination pharmacotherapy
Active Comparator group
Description:
Combined solifenacin 5mg and mirabegron 25mg once per day.
Treatment:
Drug: Combination pharmacotherapy

Trial contacts and locations

1

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Central trial contact

Hui-Hsuan Lau, MD

Data sourced from clinicaltrials.gov

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