Clinical Trials in Taiwan / NCT06197295
Recruiting
Phase 4
Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity
NCT06197295 · tracked via the Priya Life Science Taiwan tracker
Condition(s) studied
Urinary Bladder, OveractiveEffect of Drug
Investigational drug(s) / intervention(s)
Solifenacin with vaginal estrogen cream →Combination pharmacotherapy
Solifenacin with vaginal estrogen cream: Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg
Combination pharmacotherapy: Solifenacin 5mg and Mirabegron 25mg
Study summary
To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.
Eligibility
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
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 NCT06197295 on ClinicalTrials.gov ↗ ← All trials in Taiwan