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NCT Number: NCT05968885

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

To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.

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Key information

Conditions

Urinary Bladder, Overactive Effect of Drug Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urodynamics Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intradetrusor Botox® (onabotulinumtoxinA) injection

Procedure

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.

Drug

Combination pharmacotherapy

Primary outcomes

  1. Short form of Urinary Distress Inventory (UDI-6)

    Time frame: 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.

  2. Short form of Incontinence Impact Questionnaire (IIQ-7)

    Time frame: 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.

  3. Overactive Bladder Symptom Score (OABSS)

    Time frame: 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 outcomes

  1. Maximum cystometric capacity

    Time frame: Assess during 3 months - 1year after treatment

    One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity

  2. Maximum detrusor pressure at first involuntary detrusor contraction

    Time frame: Assess during 3 months - 1year after treatment

    One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity

  3. Volume at first involuntary detrusor contraction

    Time frame: Assess during 3 months - 1year after treatment

    One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsuan Lau, MD

CONTACT

[email protected]

+886-2-25433535

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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