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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Cough Stress Test; Other: 24 Hour Pad Test

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UC Irvine Women's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Karen L Noblett, MD, UCI Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 6, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Stress urinary incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2007-5923