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The purpose of this research study is to identify if the cough stress test is equal to the 24hour pad test in assessing stress urinary incontinence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cough Stress Test | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data will be analyzed at study completion at approximately 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data will be analyzed at study completion at approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karen L Noblett, MD | UCI Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Women's Healthcare | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 24 Hour Pad Test | Other | 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. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |