Refractory Urge Incontinence and Botox Injections

Sponsor

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

Overall Status

Terminated

CT.gov ID

NCT00373789

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

10.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Detrusor Overactivity Urinary Urgency Urge Urinary Incontinence	Drug: Botulinum Toxin A, bladder detrusor muscle injection Drug: Vehicle saline as placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Refractory Urge Incontinence and Botox Injections

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botox A 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 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. Other Names: Botox
Placebo Comparator: Placebo 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 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

Arm

Intervention/Treatment

Experimental: Botox A

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

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.

Other Names:

Botox

Placebo Comparator: Placebo

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

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

Outcome Measures

Primary Outcome Measures

Time to recurrence of detrusor overactivity incontinence symptoms [6 months]
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.

Secondary Outcome Measures

Change in incontinence episode frequency by bladder diary [At 12 mos after first injection., but no less than 1 mo after second injection]
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.
Incontinence-related and health-related quality of life [At 12 mos after first injection, but no less than 1 mo after second injection.]
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.
Voiding dysfunction requiring catheterization [throughout 12-month study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35249
2	USCD Medical Center	La Jolla	California	United States	92037
3	Kaiser Permanente	San Diego	California	United States	92120
4	Loyola University	Maywood	Illinois	United States	60153
5	University of North Carolina	Chapel Hill	North Carolina	United States	27599
6	Cleveland Clinic	Cleveland	Ohio	United States	44195
7	UT Southwestern	Dallas	Texas	United States	35249
8	Univeristy of Utah	Salt Lake City	Utah	United States	84132