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

Urinary Bladder, Overactive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01750645
• Other study ID #: COLS-201207
• Status: Active, not recruiting
• Phase: N/A
• First received: December 11, 2012
• Last updated: December 13, 2012
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: December 2012
• Source: Clínica Infantil Colsubsidio
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: IRB Clínica Infantil Colsubsidio
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• Intradetrusor Injection of Type-A Botulinum Toxin

Other:
• Other interventions analyzed according to protocol
Placebo Different dosage of Type-A Botulinum Toxin injected Anticholinergic drugs

Locations

Country	Name	City	State
Colombia	Clínica Infantil Colsubsidio	Bogotá DC

Sponsors (1)

Lead Sponsor	Collaborator
Clínica Infantil Colsubsidio

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence)		Minimun follow-up period of 12 weeks	No
Secondary	Adverse events to treatment (urinary retention and urinary tract infections)		Minimun follow-up period of 12 weeks	Yes
Secondary	Change in quality of life		Minimun follow-up period of 12 weeks	No
Secondary	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.	Minimun follow-up period of 12 weeks	No