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Evaluation 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
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
August 29, 2005
Last Updated
May 31, 2011
Sponsor
Pfizer
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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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