Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review

December 13, 2012 updated by: Hugo Enrique López, MD, Clínica Infantil Colsubsidio

Management of the Idiopathic Overactive Bladder With Intradetrusor Injection of Type-A Botulinum Toxin: Systematic Review of the Literature

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

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

Study Locations

  • Colombia
      • Bogotá DC, Colombia
        • Clínica Infantil Colsubsidio

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with idiopathic overactive bladder

Description

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 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?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Other: Other interventions analyzed according to protocol
  • Placebo
  • Different dosage of Type-A Botulinum Toxin injected
  • Anticholinergic drugs
Intervention Group
Drug: Intradetrusor Injection of Type-A Botulinum Toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence)
Time Frame: Minimun follow-up period of 12 weeks
Minimun follow-up period of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events to treatment (urinary retention and urinary tract infections)
Time Frame: Minimun follow-up period of 12 weeks
Minimun follow-up period of 12 weeks
Change in quality of life
Time Frame: Minimun follow-up period of 12 weeks
Minimun follow-up period of 12 weeks
Change in urodynamic measures
Time Frame: Minimun follow-up period of 12 weeks
Increase in maximum cystometric capacity, first desire to void, normal desire to void, postvoid residual volume, and the presence/abscence of detrusor overactivity.
Minimun follow-up period of 12 weeks

Collaborators and Investigators

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

Sponsor

Clínica Infantil Colsubsidio

Investigators

  • Principal Investigator: Hugo E López, MD, Clínica Infantil Colsubsidio

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

July 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLS-201207

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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