Clinical trial NCT00373789: Refractory Urge Incontinence and Botox Injections
Official title: Refractory Urge Incontinence and Botox Injections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Incontinence
Detrusor Overactivity
Urinary Urgency
Urge Urinary Incontinence
Keywords: Botulinum Toxin A
Urinary Incontinence
Detrusor Overactivity
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2006-09-08
Enrollment: 87
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Time to recurrence of detrusor overactivity incontinence symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Change in incontinence episode frequency by bladder diary
timeFrame: At 12 mos after first injection., but no less than 1 mo after second injection
measure: Incontinence-related and health-related quality of life
timeFrame: At 12 mos after first injection, but no less than 1 mo after second injection.
measure: Voiding dysfunction requiring catheterization
timeFrame: throughout 12-month study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: La Jolla
country: United States
facility: USCD Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: Univeristy of Utah
state: Utah
Study officials:
affiliation: Loyola University
name: Linda Brubaker, MD
role: STUDY_CHAIR
References:
citation: 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.