Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?
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|ClinicalTrials.gov Identifier: NCT01123096|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : July 1, 2013
|Condition or disease||Intervention/treatment|
|Stress Urinary Incontinence||Procedure: Cough Stress Test Other: 24 Hour Pad Test|
The 24 hour pad test involves women collecting their pre-weighed incontinence pads for 24 hours and returning them to the clinician for weighing. This allows for accurate quantification of urine loss. This test is often used in clinical studies before and after intervention to assess efficacy of treatment.
The cough stress test is an alternative testing modality used to evaluate stress incontinence. It is an easy test to perform in a single visit to the clinician's office and the results are immediately available. It involves the patient coughing forcefully with a full bladder and watching for leakage of urine through the urethra.
In our study, our primary aim is to compare the equivalency of the cough stress test to the 24 hour pad test as a measure of stress urinary incontinence. Our secondary aim will be to assess patient comfort and satisfaction with each of the testing modalities. If the cough stress test is equivalent, it will provide an additional, easy to use tool for patient evaluation.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?|
|Study Start Date :||September 2007|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
Stress Urinary Incontinence
Patients with the primary complaint of stress incontinence with minimal or no urge incontinence symptoms. They must be able to read English as the study involves use of validated questionnaires which have only been validated in English.
Procedure: Cough Stress Test
A cough stress test is performed by using a catheter to introduce 300ml of sterile water into the bladder. The patient is then asked to stand and cough forcefully and the clinician will observe for urine loss.Other: 24 Hour Pad Test
The patient will be provided with a standard number of pads in a sealed bag that have been pre-weighed. The patient will wear the pads for 24 consecutive hours then return the all the pads within the bag for weighing post usage.
- The primary aim is to compare the equivalency of the cough stress test to the 24 hour pad test as a measure of stress urinary incontinence. [ Time Frame: Data will be analyzed at study completion at approximately 3 years. ]
- The secondary aim will be to assess patient comfort and satisfaction with each of the testing modalities. If the cough stress test is equivalent, it will provide an additional, easy to use tool for patient evaluation. [ Time Frame: Data will be analyzed at study completion at approximately 3 years ]
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): NCT01123096
|United States, California|
|UC Irvine Women's Healthcare|
|Orange, California, United States, 92868|
|Principal Investigator:||Karen L Noblett, MD||UCI Medical Center|