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Refractory Urge Incontinence and Botox Injections

This study has been terminated.
(higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00373789
First received: September 6, 2006
Last updated: January 9, 2011
Last verified: October 2010

September 6, 2006
January 9, 2011
June 2006
December 2007   (final data collection date for primary outcome measure)
Time to recurrence of detrusor overactivity incontinence symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Questionnaire time to recurrence of detrusor overactivity incontinence symptoms
Complete list of historical versions of study NCT00373789 on ClinicalTrials.gov Archive Site
  • Change in incontinence episode frequency by bladder diary [ Time Frame: At 12 mos after first injection., but no less than 1 mo after second injection ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 12 mos after first injection, but no less than 1 mo after second injection. ] [ Designated as safety issue: No ]
    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 [ Time Frame: throughout 12-month study ] [ Designated as safety issue: Yes ]
  • Change in incontinence episode frequency by bladder diary
  • Incontinence-related quality of life
  • Health-related quality of life
  • Voiding dysfunction requiring catheterization
Not Provided
Not Provided
 
Refractory Urge Incontinence and Botox Injections
Refractory Urge Incontinence and Botox Injections

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Urinary Incontinence
  • Detrusor Overactivity
  • Urinary Urgency
  • Urge Urinary Incontinence
  • 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 Name: Botox
  • 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
  • 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
    Intervention: Drug: Botulinum Toxin A, bladder detrusor muscle injection
  • 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
    Intervention: Drug: Vehicle saline as placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
87
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373789
PFDN 12
Yes
Susan Meikle, MD, NICHD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Study Chair: Linda Brubaker, MD Loyola University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP