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Sponsors and Collaborators: |
Pneumoflex Systems, LLC Ockham Development Group Inc. |
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Information provided by: | Pneumoflex Systems, LLC |
ClinicalTrials.gov Identifier: | NCT00801203 |
This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI) in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic testing by evaluation of sensitivity and specificity.
Condition | Intervention | Phase |
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Stress Urinary Incontinence |
Procedure: IRCT |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Controlled Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence |
Estimated Enrollment: | 180 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Induced Reflex Cough Test (IRCT) followed by Voluntary Cough Test (VCT)
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Procedure: IRCT
Up to two administrations of the IRCT during a single cough testing session
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2: Experimental
Voluntary Cough Test (VCT) followed by Induced Reflex Cough Test (IRCT)
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Procedure: IRCT
Up to two administrations of the IRCT during a single cough testing session
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Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa K. Mallard | 910-341-7694 | lkmallard@ockham.com |
Contact: Mary Jo Bullard | 910-341-7694 | mjbullard@ockham.com |
United States, Florida | |
Clinical Physiology Associates, Inc | Recruiting |
Cape Coral, Florida, United States, 33990 | |
United States, Louisiana | |
Regional Urology, LLC | Recruiting |
Shreveport, Louisiana, United States, 71106 | |
United States, New York | |
University Urology Associates | Not yet recruiting |
Manhattan, New York, United States, 10016 | |
Accumed Research Associates | Not yet recruiting |
Garden City, New York, United States, 11530 | |
United States, Pennsylvania | |
Urologic Consultants of SE PA | Recruiting |
Bala Cynwyd, Pennsylvania, United States, 19004 | |
United States, South Carolina | |
Carolina Urologic Research Center | Recruiting |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Texas | |
Urology Associates of South Texas | Recruiting |
McAllen, Texas, United States, 78503 | |
Urology San Antonio Research | Recruiting |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
Advanced Clinical Research | Recruiting |
West Jordan, Utah, United States, 84088 |
Study Director: | Robert Addington, D.O. | Pneumoflex Systems, LLC |
Responsible Party: | Pneumoflex Systems, LLC ( W. Robert Addington, D.O., President ) |
Study ID Numbers: | PNEU-01-004 |
Study First Received: | December 1, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00801203 |
Health Authority: | United States: Food and Drug Administration |
Stress Urinary Incontinence |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases Urination Disorders |
Stress Cough Urinary Incontinence |
Urological Manifestations Pathologic Processes |