Overview

This trial is active, not recruiting.

Condition urinary bladder, overactive
Treatments intradetrusor injection of type-a botulinum toxin, other interventions analyzed according to protocol
Sponsor Clínica Infantil Colsubsidio
Start date July 2012
End date October 2012
Trial identifier NCT01750645, COLS-201207

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

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

Secondary Outcomes

Measure
Adverse events to treatment (urinary retention and urinary tract infections)
time frame: Minimun follow-up period of 12 weeks
Change in quality of life
time frame: Minimun follow-up period of 12 weeks
Change in urodynamic measures
time frame: Minimun follow-up period of 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Management of the Idiopathic Overactive Bladder With Intradetrusor Injection of Type-A Botulinum Toxin: Systematic Review of the Literature
Principal investigator Hugo E López, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Clínica Infantil Colsubsidio.