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

NCT06479720 · tracked via the Priya Life Science Taiwan tracker

Sponsor

Mackay Memorial Hospital

Phase

Phase 4

Started

2022-06-16

Last updated

2025-05-09

Condition(s) studied

Effect of DrugUrinary Bladder, Overactive

Investigational drug(s) / intervention(s)

Combined pharmacotherapy with Solifenacin and MirabegronSolifenacin with vaginal estrogen cream →Mirabegron with vaginal estrogen cream

Combined pharmacotherapy with Solifenacin and Mirabegron: Solifenacin (5mg) is anticholinergic and Mirabegron (25mg) is a beta-3 adrenergic agonist.

Solifenacin with vaginal estrogen cream: Solifenacin (5mg) is anticholinergic. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).

Mirabegron with vaginal estrogen cream: Mirabegron (25mg) is a beta-3 adrenergic agonist. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).

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

Sex

FEMALE

Min age

40 Years

Max age

90 Years

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.

Primary outcome measure(s)

Short form of Urinary Distress Inventory (UDI-6) — Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence.
Short form of Incontinence Impact Questionnaire (IIQ-7) — Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships \& emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence.
Overactive Bladder Symptom Score (OABSS) — Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms.

Trial sites (1)

Facility	City	Region	Status
Mackay Memorial Hospital	Taipei	Taiwan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06479720 on ClinicalTrials.gov ↗ ← All trials in Taiwan