Refractory Urge Incontinence and Botox Injections

This study is ongoing, but not recruiting participants.

First Received: September 6, 2006 Last Updated: June 19, 2007 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00373789

Purpose

The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.

Condition	Intervention	Phase
Urinary Incontinence Detrusor Overactivity Urinary Urgency Urge Urinary Incontinence	Drug: Botulinum Toxin A, bladder detrusor muscle injection Drug: Vehicle saline as placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Refractory Urge Incontinence and Botox Injections

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Questionnaire time to recurrence of detrusor overactivity incontinence symptoms

Secondary Outcome Measures:

Change in incontinence episode frequency by bladder diary
Incontinence-related quality of life
Health-related quality of life
Voiding dysfunction requiring catheterization

Estimated Enrollment:	210
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2007

Detailed Description:

Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult women
Detrusor overactivity incontinence confirmed by urodynamic testing
Symptoms refractory to standard first- and second-line treatments
6 or more urge incontinence episodes on 3-day bladder diary
Normal neurological examination

Exclusion Criteria:

Urinary retention
Allergy to Botox (Botulinum Toxin A)
Previous bladder treatment with Botox (Botulinum Toxin A) in the past year
Pregnancy or planning pregnancy within next year
Neurologic disease with impaired neurotransmission

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373789

Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
United States, California
USCD Medical Center
La Jolla, California, United States, 92037
Kaiser Permanente
San Diego, California, United States, 92120
United States, Illinois
Loyola University
Maywood, Illinois, United States, 60153
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
UT Southwestern
Dallas, Texas, United States, 35249
United States, Utah
Univeristy of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Director:	Anne M Weber, MD, MS	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator:	Morton B Brown, PhD	Data Coordinating Center, University of Michigan

More Information

Additional Information:

Public website for the Pelvic Floor Disorders Network This link exits the ClinicalTrials.gov site

Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network This link exits the ClinicalTrials.gov site

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. Epub 2008 May 21.

Study ID Numbers:	PFDN 12
Study First Received:	September 6, 2006
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00373789 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Botulinum Toxin A
Urinary Incontinence
Detrusor Overactivity

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Botulinum Toxins
Urologic Diseases
Anti-Dyskinesia Agents
Urination Disorders

Therapeutic Uses
Urinary Incontinence
Urinary Incontinence, Urge
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010