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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hugo Enrique López, MD, Clínica Infantil Colsubsidio
ClinicalTrials.gov Identifier:
NCT01750645
First received: December 11, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Urinary Bladder, Overactive
 Drug: Intradetrusor Injection of Type-A Botulinum Toxin
Other: Other interventions analyzed according to protocol

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

Further study details as provided by Clínica Infantil Colsubsidio:

Primary Outcome Measures:
  • Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence) [ Time Frame: Minimun follow-up period of 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events to treatment (urinary retention and urinary tract infections) [ Time Frame: Minimun follow-up period of 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in quality of life [ Time Frame: Minimun follow-up period of 12 weeks ] [ Designated as safety issue: No ]
  • Change in urodynamic measures [ Time Frame: Minimun follow-up period of 12 weeks ] [ Designated as safety issue: No ]
    Increase in maximum cystometric capacity, first desire to void, normal desire to void, postvoid residual volume, and the presence/abscence of detrusor overactivity.


Study Start Date: July 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention Group Drug: Intradetrusor Injection of Type-A Botulinum Toxin
Control Group Other: Other interventions analyzed according to protocol
  • Placebo
  • Different dosage of Type-A Botulinum Toxin injected
  • Anticholinergic drugs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients diagnosed with idiopathic overactive bladder

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750645

Locations
Colombia
Clínica Infantil Colsubsidio
Bogotá DC, Colombia
Sponsors and Collaborators
Clínica Infantil Colsubsidio
Investigators
Principal Investigator: Hugo E López, MD Clínica Infantil Colsubsidio
  More Information

No publications provided

Responsible Party: Hugo Enrique López, MD, MD, Clínica Infantil Colsubsidio
ClinicalTrials.gov Identifier: NCT01750645     History of Changes
Other Study ID Numbers: COLS-201207
Study First Received: December 11, 2012
Last Updated: December 13, 2012
Health Authority: Colombia: IRB Clínica Infantil Colsubsidio

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
 Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013