Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Overview
- Phase
- Phase 4
- Intervention
- Intradetrusor Botox® (onabotulinumtoxinA) injection
- Conditions
- Urinary Bladder, Overactive
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Short form of Incontinence Impact Questionnaire (IIQ-7)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
Detailed Description
Patients with detrusor overactivity who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. Patient were divided in two groups, intradetrusor onabotulinumtoxinA injection and combined pharmacotherapy with Mirabegron and Solifenacin. 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 daily urgency episodes, urinary incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (Pdetmax) at first involuntary detrusor contraction and volume at first involuntary detrusor contraction were measured.
Investigators
Hui-Hsuan Lau, MD
Head of urogynecology, Associate Professor
Mackay Memorial Hospital
Eligibility Criteria
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 either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study
Exclusion Criteria
- •Postvoid urine retention before treatment
Arms & Interventions
Intradetrusor onabotulinumtoxinA injection
The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
Intervention: Intradetrusor Botox® (onabotulinumtoxinA) injection
Combination pharmacotherapy
Combine Mirabegron and Solifenacin.
Intervention: Combine Mirabegron and Solifenacin.
Outcomes
Primary Outcomes
Short form of Incontinence Impact Questionnaire (IIQ-7)
Time Frame: 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.
Short form of Urinary Distress Inventory (UDI-6)
Time Frame: 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.
Overactive Bladder Symptom Score (OABSS)
Time Frame: 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 Outcomes
- Maximum cystometric capacity(Assess during 3 months - 1year after treatment)
- Maximum detrusor pressure at first involuntary detrusor contraction(Assess during 3 months - 1year after treatment)
- Volume at first involuntary detrusor contraction(Assess during 3 months - 1year after treatment)