Effect of Drug, Urinary Bladder, Overactive, Urodynamics
Conditions
Keywords
Detrusor overactivity, Urodynamic study, Combined pharmacotherapy, Botulinum Toxins, Effectiveness
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.
Interventions
PROCEDUREIntradetrusor Botox® (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.
DRUGCombine Mirabegron and Solifenacin.
Combination pharmacotherapy
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum cystometric capacity | Assess during 3 months - 1year after treatment | One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity |
| Maximum detrusor pressure at first involuntary detrusor contraction | Assess during 3 months - 1year after treatment | One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity |
| Volume at first involuntary detrusor contraction | Assess during 3 months - 1year after treatment | One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity |
Countries
Taiwan
Contacts
Primary ContactHui-Hsuan Lau, MD
Outcome results
None listed