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Recruiting Phase 4

Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity

NCT05968885 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 4
Started
2021-10-01
Last updated
2025-05-09

Condition(s) studied

Urinary Bladder, OveractiveUrodynamicsEffect of Drug

Investigational drug(s) / intervention(s)

Intradetrusor Botox® (onabotulinumtoxinA) injectionCombine Mirabegron and Solifenacin.

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

Sex
FEMALE
Min age
20 Years
Max age
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

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)

FacilityCityRegionStatus
Mackay Memorial Hospital Taipei Taiwan Recruiting
Official registry record

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