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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141128
First received: August 29, 2005
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00141128     History of Changes
Other Study ID Numbers: A6061024
Study First Received: August 29, 2005
Last Updated: May 31, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013