Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?

NCT ID: NCT01123096

Last Updated: 2013-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cough Stress Test

Intervention Type 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.

24 Hour Pad Test

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Karen Noblett

Division Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen L Noblett, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Medical Center

Locations

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UC Irvine Women's Healthcare

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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2007-5923

Identifier Type: -

Identifier Source: org_study_id

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