Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Condition(s) studied
Investigational drug(s) / intervention(s)
Intradetrusor 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.
Combine Mirabegron and Solifenacin.: Combination pharmacotherapy
Study summary
To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Mackay Memorial Hospital | Taipei | Taiwan | Recruiting |
More Mackay Memorial Hospital trials in Taiwan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05968885 on ClinicalTrials.gov ↗ ← All trials in Taiwan