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Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.

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ClinicalTrials.gov Identifier: NCT00141128
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : June 1, 2011
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Study Description
Brief Summary:
SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Drug: SS-RBX Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.

Secondary Outcome Measures :
  1. To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female
  • Stress urinary incontinence

Exclusion Criteria:

  • Bladder outflow obstruction
  • Neurological disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141128

Pfizer Investigational Site
Glostrup, Denmark, 2600
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00141128     History of Changes
Other Study ID Numbers: A6061024
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders