Refractory Urge Incontinence and Botox Injections

Urinary Incontinence Clinical Trial

Official title:

Refractory Urge Incontinence and Botox Injections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00373789
• Other study ID #: PFDN 12
• Status: Terminated
• Phase: Phase 3
• First received: September 6, 2006
• Last updated: January 9, 2011
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: October 2010
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Detrusor Overactivity
• Urge Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Urge
• Urinary Urgency

Intervention

Drug:
• Botulinum Toxin A, bladder detrusor muscle injection
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.
• Vehicle saline as placebo
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

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	UT Southwestern	Dallas	Texas
United States	USCD Medical Center	La Jolla	California
United States	Loyola University	Maywood	Illinois
United States	Univeristy of Utah	Salt Lake City	Utah
United States	Kaiser Permanente	San Diego	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in incontinence episode frequency by bladder diary	based on the 3-day bladder diary completed pre-intervention and at 4 weeks post injection. A successful within-subject outcome will be defined as >75% reduction in the frequency of urge incontinence episodes compared to the baseline frequency.	At 12 mos after first injection., but no less than 1 mo after second injection	No
Secondary	Incontinence-related and health-related quality of life	measured by the Urinary Distress Inventory subscale of the PFDI/PFIQ, the PISQ, and SF-36 administered at 4 weeks after the initial injection and either prior to any re-treatment or at the completion of study participation, whichever is earlier.	At 12 mos after first injection, but no less than 1 mo after second injection.	No
Secondary	Voiding dysfunction requiring catheterization		throughout 12-month study	Yes

External Links

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