- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141128
Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
May 31, 2011 updated by: Pfizer
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.
SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glostrup, Denmark, 2600
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Stress urinary incontinence
Exclusion Criteria:
- Bladder outflow obstruction
- Neurological disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
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Secondary Outcome Measures
Outcome Measure |
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To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
August 29, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
June 1, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6061024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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