Status:

RECRUITING

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

Lead Sponsor:

Mackay Memorial Hospital

Conditions:

Urinary Bladder, Overactive

Effect of Drug

Eligibility:

FEMALE

40-90 years

Phase:

PHASE4

Brief Summary

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

Detailed 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 solifenac...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 16 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06197295

Start Date

June 16 2022

End Date

December 31 2026

Last Update

May 9 2025

Active Locations (1)

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1

Mackay Memorial Hospital

Taipei, Taiwan