NCT05968885

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

Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder, Overactive
• Urodynamics
• Effect of Drug

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	Combine Mirabegron and Solifenacin.	Combination pharmacotherapy

Timeline

• Start date: 2021-10-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2023-08-01
• Last updated: 2025-05-09

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study