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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Noblett, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01123096
First received: May 6, 2010
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Procedure: Cough Stress Test
Other: 24 Hour Pad Test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123096

Locations
United States, California
UC Irvine Women's Healthcare
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen L Noblett, MD UCI Medical Center
  More Information

No publications provided

Responsible Party: Karen Noblett, Division Director, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01123096     History of Changes
Other Study ID Numbers: 2007-5923
Study First Received: May 6, 2010
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
Stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014