Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity
- Conditions
- Urinary Bladder, OveractiveEffect of Drug
- Interventions
- Drug: Combination pharmacotherapy
- Registration Number
- NCT06197295
- Lead Sponsor
- Mackay Memorial Hospital
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Solifenacin with vaginal estrogen cream Solifenacin with vaginal estrogen cream Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week. Combination pharmacotherapy Combination pharmacotherapy Combined solifenacin 5mg and mirabegron 25mg once per day.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Episodes of daily micturition Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment Patients report daily lower urinary tract symptoms episodes
Episodes of daily nocturia Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment Patients report daily lower urinary tract symptoms episodes
Episodes of daily urgency Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment Patients report daily lower urinary tract symptoms episodes
Episodes of daily incontinence Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment Patients report daily lower urinary tract symptoms episodes
Trial Locations
- Locations (1)
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan