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

July 29, 2023 updated by: Hui-Hsuan Lau, Mackay Memorial Hospital

Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intradetrusor 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.
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.
Experimental: Combination pharmacotherapy
Combine Mirabegron and Solifenacin.
Drug: Combine Mirabegron and Solifenacin.
Combination pharmacotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
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.
Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
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.
Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assess during 3 months - 1year after treatment
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
Assess during 3 months - 1year after treatment
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
Assess during 3 months - 1year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: Hui-Hsuan Lau, MD, Mackay Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

July 29, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22MMHIS039e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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