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Refractory Urge Incontinence and Botox Injections

Primary Purpose

Urinary Incontinence, Detrusor Overactivity, Urinary Urgency

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin A, bladder detrusor muscle injection
Vehicle saline as placebo
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Botulinum Toxin A, Urinary Incontinence, Detrusor Overactivity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Alabama
  • USCD Medical Center
  • Kaiser Permanente
  • Loyola University
  • University of North Carolina
  • Cleveland Clinic
  • UT Southwestern
  • Univeristy of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botox A

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Voiding dysfunction requiring catheterization

Full Information

First Posted
September 6, 2006
Last Updated
January 9, 2011
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00373789
Brief Title
Refractory Urge Incontinence and Botox Injections
Official Title
Refractory Urge Incontinence and Botox Injections
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Detrusor Overactivity, Urinary Urgency, Urge Urinary Incontinence
Keywords
Botulinum Toxin A, Urinary Incontinence, Detrusor Overactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox A
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Botulinum Toxin A, bladder detrusor muscle injection
Other Intervention Name(s)
Botox
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vehicle saline as placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to recurrence of detrusor overactivity incontinence symptoms
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in incontinence episode frequency by bladder diary
Description
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.
Time Frame
At 12 mos after first injection., but no less than 1 mo after second injection
Title
Incontinence-related and health-related quality of life
Description
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.
Time Frame
At 12 mos after first injection, but no less than 1 mo after second injection.
Title
Voiding dysfunction requiring catheterization
Time Frame
throughout 12-month study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Brubaker, MD
Organizational Affiliation
Loyola University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
USCD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
35249
Country
United States
Facility Name
Univeristy of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18499184
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.
Results Reference
result
Links:
URL
http://www.nichd.nih.gov
Description
Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network

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Refractory Urge Incontinence and Botox Injections

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