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

Phase 4

Recruiting

• Conditions: Urodynamics; Urinary Bladder, Overactive; Effect of Drug
• Interventions: Procedure: Intradetrusor Botox® (onabotulinumtoxinA) injection; Drug: Combine Mirabegron and Solifenacin.

• Registration Number: NCT05968885
• Lead Sponsor: Mackay Memorial Hospital

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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-07-29
• Study First Posted: 2023-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradetrusor onabotulinumtoxinA injection	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.
Combination pharmacotherapy	Combine Mirabegron and Solifenacin.	Combine Mirabegron and Solifenacin.

Primary Outcome Measures

Name	Time	Method
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.
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.
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan