To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
Combination pharmacotherapy
Mackay Memorial Hospital
Taipei, Taiwan
RECRUITINGShort 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
Maximum cystometric capacity
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Time frame: Assess during 3 months - 1year after treatment
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Maximum detrusor pressure at first involuntary detrusor contraction
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Time frame: Assess during 3 months - 1year after treatment
Volume at first involuntary detrusor contraction
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Time frame: Assess during 3 months - 1year after treatment