Clinical trial NCT01123096: Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?
Official title: Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* patients unable to stand (to perform standing stress test), patients with leakage from a urinary tract fistula, use of vaginal creams within 72 hours of the pad test, active vaginal infection, sexual intercourse within 24 hours of the pad test and patients who do not read English.

Primary outcomes:
measure: 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.
timeFrame: Data will be analyzed at study completion at approximately 3 years.
Secondary outcomes:
measure: 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.
timeFrame: Data will be analyzed at study completion at approximately 3 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Women's Healthcare
state: California
Study officials:
affiliation: UCI Medical Center
name: Karen L Noblett, MD
role: PRINCIPAL_INVESTIGATOR
References: