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

Primary Purpose

Urinary Bladder, Overactive, Urodynamics, Effect of Drug

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Intradetrusor Botox® (onabotulinumtoxinA) injection
Combine Mirabegron and Solifenacin.
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Detrusor overactivity, Urodynamic study, Combined pharmacotherapy, Botulinum Toxins, Effectiveness

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intradetrusor onabotulinumtoxinA injection

Combination pharmacotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Maximum cystometric capacity
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Maximum detrusor pressure at first involuntary detrusor contraction
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Volume at first involuntary detrusor contraction
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity

Full Information

First Posted
March 2, 2023
Last Updated
July 29, 2023
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05968885
Brief Title
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Official Title
Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive, Urodynamics, Effect of Drug
Keywords
Detrusor overactivity, Urodynamic study, Combined pharmacotherapy, Botulinum Toxins, Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intradetrusor onabotulinumtoxinA injection
Arm Type
Active Comparator
Arm Description
The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
Arm Title
Combination pharmacotherapy
Arm Type
Experimental
Arm Description
Combine Mirabegron and Solifenacin.
Intervention Type
Procedure
Intervention Name(s)
Intradetrusor Botox® (onabotulinumtoxinA) injection
Intervention Description
The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
Intervention Type
Drug
Intervention Name(s)
Combine Mirabegron and Solifenacin.
Intervention Description
Combination pharmacotherapy
Primary Outcome Measure Information:
Title
Short form of Urinary Distress Inventory (UDI-6)
Description
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.
Time Frame
Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Title
Short form of Incontinence Impact Questionnaire (IIQ-7)
Description
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.
Time Frame
Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Title
Overactive Bladder Symptom Score (OABSS)
Description
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.
Time Frame
Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary Outcome Measure Information:
Title
Maximum cystometric capacity
Description
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Time Frame
Assess during 3 months - 1year after treatment
Title
Maximum detrusor pressure at first involuntary detrusor contraction
Description
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Time Frame
Assess during 3 months - 1year after treatment
Title
Volume at first involuntary detrusor contraction
Description
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Time Frame
Assess during 3 months - 1year after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study focus on female detrusor overactivity.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Hsuan Lau, MD
Phone
+886-2-25433535
Email
huihsuan1220@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Hsuan Lau, MD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiun Chyi Hwang, MD
Phone
+886-2-2543-3535
Email
jiun1989@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31039103
Citation
Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
Results Reference
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PubMed Identifier
30644570
Citation
Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15.
Results Reference
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Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity

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