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

Phase 4RecruitingNCT06197295

Mackay Memorial Hospital200 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Urinary Bladder, Overactive Effect of Drug

Interventions

Solifenacin with vaginal estrogen creamDRUG

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

Combination pharmacotherapyDRUG

Solifenacin 5mg and Mirabegron 25mg

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Short form of Urinary Distress Inventory (UDI-6)

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.

Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

Short form of Incontinence Impact Questionnaire (IIQ-7)

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.

Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

Overactive Bladder Symptom Score (OABSS)

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.

Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

Secondary Outcomes

Episodes of daily micturition

Patients report daily lower urinary tract symptoms episodes

Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

Central Contacts

Hui-Hsuan Lau, MD

CONTACT

+886-2-25433535 huihsuan1220@gmail.com

Data from ClinicalTrials.gov

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