Refractory Urge Incontinence and Botox Injections

NCT00373789 | Terminated Phase 3 DMC

• 1 other identifier: PFDN 12
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Urinary Incontinence; Detrusor Overactivity; Urinary Urgency; Urge Urinary Incontinence

Keywords

Botulinum Toxin A; Urinary Incontinence; Detrusor Overactivity

Outcome Measures

Primary Outcomes (1)

• Time to recurrence of detrusor overactivity incontinence symptoms

  To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI.

  6 months

Secondary Outcomes (3)

• Change in incontinence episode frequency by bladder diary

  At 12 mos after first injection., but no less than 1 mo after second injection

• Incontinence-related and health-related quality of life

  At 12 mos after first injection, but no less than 1 mo after second injection.

• Voiding dysfunction requiring catheterization

  throughout 12-month study

Study Arms (2)

Botox A

EXPERIMENTAL

up to two injections of 200 Units of intra-detrusor Botulinum Toxin A , which must be separated by at least eight weeks and no more than 52 weeks

Drug: Botulinum Toxin A, bladder detrusor muscle injection

Placebo

PLACEBO COMPARATOR

up to two injections of inactive injection (carrier saline), which must be separated by at least eight weeks and no more than 52 weeks

Drug: Vehicle saline as placebo

Interventions

Botulinum Toxin A, bladder detrusor muscle injection DRUG

200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.

Also known as: Botox

Botox A

Vehicle saline as placebo DRUG

A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (8)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

USCD Medical Center

La Jolla, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92120, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UT Southwestern

Dallas, Texas, 35249, United States

Location

Univeristy of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.

  PMID: 18499184 RESULT

Related Links

• Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Linda Brubaker, MD

  Loyola University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 8, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 11, 2011

Record last verified: 2010-10

Locations

US (8)