Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review
Primary Purpose
Urinary Bladder, Overactive
Status
Unknown status
Phase
Locations
Colombia
Study Type
Observational
Intervention
Intradetrusor Injection of Type-A Botulinum Toxin
Other interventions analyzed according to protocol
Sponsored by
About this trial
This is an observational trial for Urinary Bladder, Overactive
Eligibility Criteria
Inclusion Criteria:
- Controlled randomized clinical trials
- Adult patients diagnosed with idiopathic overactive bladder
- Language of the study: english
Exclusion Criteria:
- Diagnosis of neurogenic overactive bladder
- Patients under 18 years old
- Use of Type-B Botulinum Toxin as the intervention
- Other types of studies
Sites / Locations
- Clínica Infantil Colsubsidio
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence)
Secondary Outcome Measures
Adverse events to treatment (urinary retention and urinary tract infections)
Change in quality of life
Change in urodynamic measures
Increase in maximum cystometric capacity, first desire to void, normal desire to void, postvoid residual volume, and the presence/abscence of detrusor overactivity.
Full Information
NCT ID
NCT01750645
First Posted
December 11, 2012
Last Updated
December 13, 2012
Sponsor
Clínica Infantil Colsubsidio
1. Study Identification
Unique Protocol Identification Number
NCT01750645
Brief Title
Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review
Official Title
Management of the Idiopathic Overactive Bladder With Intradetrusor Injection of Type-A Botulinum Toxin: Systematic Review of the Literature
Study Type
Observational
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clínica Infantil Colsubsidio
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one of the available treatments is the injection of Botulinum Toxin. This study aims to review the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the controlled randomized clinical trials were chosen to review with the CONSORT criteria by independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment, change in quality of life and urodynamic measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
7. Study Design
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Title
Control Group
Intervention Type
Drug
Intervention Name(s)
Intradetrusor Injection of Type-A Botulinum Toxin
Intervention Type
Other
Intervention Name(s)
Other interventions analyzed according to protocol
Intervention Description
Placebo
Different dosage of Type-A Botulinum Toxin injected
Anticholinergic drugs
Primary Outcome Measure Information:
Title
Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence)
Time Frame
Minimun follow-up period of 12 weeks
Secondary Outcome Measure Information:
Title
Adverse events to treatment (urinary retention and urinary tract infections)
Time Frame
Minimun follow-up period of 12 weeks
Title
Change in quality of life
Time Frame
Minimun follow-up period of 12 weeks
Title
Change in urodynamic measures
Description
Increase in maximum cystometric capacity, first desire to void, normal desire to void, postvoid residual volume, and the presence/abscence of detrusor overactivity.
Time Frame
Minimun follow-up period of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Controlled randomized clinical trials
Adult patients diagnosed with idiopathic overactive bladder
Language of the study: english
Exclusion Criteria:
Diagnosis of neurogenic overactive bladder
Patients under 18 years old
Use of Type-B Botulinum Toxin as the intervention
Other types of studies
Study Population Description
Adult patients diagnosed with idiopathic overactive bladder
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo E López, MD
Organizational Affiliation
Clínica Infantil Colsubsidio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica Infantil Colsubsidio
City
Bogotá DC
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review
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