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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 23, 2014