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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141128
First Posted: September 1, 2005
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology

Condition Intervention Phase
Urinary Incontinence, Stress Drug: SS-RBX Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.

Enrollment: 18
Study Start Date: December 2005
Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

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

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


Locations
Denmark
Pfizer Investigational Site
Glostrup, Denmark, 2600
Sponsors and Collaborators
Pfizer
Investigators
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 Submitted: August 29, 2005
First Posted: September 1, 2005
Last Update Posted: June 1, 2011
Last Verified: May 2011

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