Back to resultsEvaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
Primary Purpose
Urinary Incontinence, Stress
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
SS-RBX
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress
Eligibility Criteria
Inclusion Criteria: Female Stress urinary incontinence Exclusion Criteria: Bladder outflow obstruction Neurological disease
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
Secondary Outcome Measures
To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00141128
Brief Title
Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
Official Title
Measurement Of Urethral Function In Women With Stress Urinary Incontinence - Evaluation Of The Sensitivity Of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine To Detect Pharmacological Augmentation Of Urethral Pressure.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SS-RBX
Primary Outcome Measure Information:
Title
To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
Secondary Outcome Measure Information:
Title
To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Stress urinary incontinence
Exclusion Criteria:
Bladder outflow obstruction
Neurological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19375093
Citation
Klarskov N, Scholfield D, Soma K, Darekar A, Mills I, Lose G. Measurement of urethral closure function in women with stress urinary incontinence. J Urol. 2009 Jun;181(6):2628-33; discussion 2633. doi: 10.1016/j.juro.2009.01.114. Epub 2009 Apr 16.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061024&StudyName=Evaluation+Of+A+Novel+Methodology+In+The+Assessment+Of+Urethral+Function+Using+SS%2DRBX%2E
Description
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Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
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