RecruitingPhase 4NCT06197295

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

Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity


Sponsor

Mackay Memorial Hospital

Enrollment

200 participants

Start Date

Jun 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 90 Years

Inclusion Criteria1

  • 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 Criteria4

  • 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

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Interventions

DRUGSolifenacin with vaginal estrogen cream

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

DRUGCombination pharmacotherapy

Solifenacin 5mg and Mirabegron 25mg


Locations(1)

Mackay Memorial Hospital

Taipei, Taiwan

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NCT06197295


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