Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-90
SponsorMackay Memorial Hospital
About this trial
To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Postvoid urine retention before treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Intradetrusor Botox® (onabotulinumtoxinA) injection
Procedure/SurgeryThe toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
Combine Mirabegron and Solifenacin.
DrugCombination pharmacotherapy
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Intradetrusor onabotulinumtoxinA injectionActive comparator 1 intervention
Group B: Combination pharmacotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatment2
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 treatment3
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 treatmentSecondary outcomes
1
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 treatment2
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 treatment3
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 treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov