Management of the Idiopathic Overactive Bladder With Botu... | NCT01750645

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

NCT01750645

Sponsor

Clínica Infantil Colsubsidio

Status

Unknown status

Last Update Posted

Dec 17, 2012Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Urinary Bladder, Overactive

Interventions

Intradetrusor Injection of Type-A Botulinum Toxin
Other interventions analyzed according to protocol

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Jan 2013Estimated

First Submitted Date

Dec 11, 2012

First Submission Date that Met QC Criteria

Dec 13, 2012

First Posted Date

Dec 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group			Drug: Intradetrusor Injection of Type-A Botulinum Toxin
Control Group			Other: Other interventions analyzed according to protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intradetrusor Injection of Type-A Botulinum Toxin	Drug		Intervention Group
Other interventions analyzed according to protocol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Adverse events to treatment (urinary retention and urinary tract infections)		Minimun follow-up period of 12 weeks
Change in quality of life		Minimun follow-up period of 12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients diagnosed with idiopathic overactive bladder

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo E López, MD	Clínica Infantil Colsubsidio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clínica Infantil Colsubsidio		Bogotá DC	Bogotá DC		Colombia

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided