Standardization of Cough Stress Test

A Randomized Comparative Study Correlating Cough Stress Test With Urodynamics And 24 Hour Pad Test In the Evaluation of Stress Urinary Incontinence

This is a multicenter, prospective, randomized comparative study in which patients are randomized to one of four different bladder volumes and a Cough Stress Test (CST) is performed in both the standing and sitting positions. The goal is to assess the agreement of each CST method with both urodynamics diagnosis of Stress Urinary Incontinence (SUI) and the 24-hour pad test. The primary outcome is to determine what CST method best correlated with either test in the diagnosis of SUI.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Cough Stress Test

Detailed Description

This multicenter, prospective randomized study is approved by the Institutional Review Boards at both the University Hospitals Case Medical Center, Cleveland, OH, USA and MetroHealth Hospital, Cleveland, OH, USA (Identifiers 07-11-37 and FWA00003938, respectively). Adult women who presented to the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) outpatient clinics at both the University Hospitals Case Medical Center and MetroHealth Hospital with symptoms of stress, urge, or mixed urinary incontinence and who were recommended by the evaluating staff to undergo urodynamic studies (UDS) are eligible. The staff physician will approach the patient for participation in this study after the standard clinic visit is completed and the initial diagnosis is made. A research coordinator will then explain the study and obtain informed consent if the patient agrees to participate. The patient will then be given instructions for a 24 hour pad test and standardized pads to use. The patient will also be given instructions for a three day voiding diary along with routine instruction regarding the urodynamic procedure. The patient will be asked to perform the 24 hour pad test the day prior to the UDS appointment. The three day voiding diary will be performed during a typical and sequential three day period during the week prior to the UDS. Patients will then asked to bring these items to the UDS appointment.

During the initial appointment with the study coordinator, patients will be randomized to 4 groups (A, B, C, and D). Patients in group A will be scheduled to undergo Cough Stress Test (CST) with a comfortably full bladder. This will be subjectively reported by the patient. Patients in group B will be scheduled to undergo CST with an empty bladder after straight catheterization. Group C patients will be scheduled to undergo CST with a bladder infused with 200 cc of saline. Patients in group D will be scheduled to undergo CST with the bladder filled to half functional capacity as determined from the largest voided volume recorded in the patient's voiding diary. CST will be performed in the standing and sitting position for each patient in each of the above groups. The sequence of performing the standing and sitting CST will be randomly assigned for each patient.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• symptoms of urinary incontinence as a chief complaint or as the reason for scheduling the clinic visit, and who were to be scheduled to undergo urodynamic (UDS) testing after initial evaluation by their physician

Exclusion Criteria:

• pelvic organ prolapse beyond stage 1 Pelvic Organ Prolapse- Quantification (POP-Q) as diagnosed by the examining physician
• any other clinical diagnosis other than urinary incontinence who undergo UDS testing ( e.g. interstitial cystitis, overactive bladder dry, bladder outlet obstruction)
• were taking alpha agonists or anticholinergic medications within 2 weeks of the testing
• had an elevated Post Void Residual (PVR) >50cc
• any physical or mental disability that would either not allow participation or impede the ability to give fully informed consent
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Cough Stress Test with a comfortably full bladder.	Procedure: Cough Stress Test; Varying bladder volumes during cough stress test.
Experimental: Group B; Cough Stress Test with an empty bladder after straight catheterization.	Procedure: Cough Stress Test; Varying bladder volumes during cough stress test.
Experimental: Group C; Cough Stress Test with a bladder infused with 200 cc of saline.	Procedure: Cough Stress Test; Varying bladder volumes during cough stress test.
Experimental: Group D; Cough Stress Test with the bladder filled to half functional capacity as determined from the largest voided volume recorded in the patient's voiding diary.	Procedure: Cough Stress Test; Varying bladder volumes during cough stress test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of cough stress test with urodynamics	To define how different accepted cough stress test methods correlated with urodynamics in the evaluation of stress urinary incontinence.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hour pad weight	To assess if there was any benefit to performing a 24 hour pad test with or without the different cough stress test modalities.	24 hours

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: urodynamics; cough stress test; pad test
• 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: 07-11-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No