Standardization of Cough Stress Test

NCT02742584 | Completed DMC

• 1 other identifier: 07-11-37
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Keywords

cough stress test; urodynamics; pad test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 24hour pad weight

  24 hours

Study Arms (4)

Group A

EXPERIMENTAL

Cough Stress Test with a comfortably full bladder.

Procedure: Cough Stress Test

Group B

EXPERIMENTAL

Cough Stress Test with an empty bladder after straight catheterization.

Procedure: Cough Stress Test

Group C

EXPERIMENTAL

Cough Stress Test with a bladder infused with 200 cc of saline.

Procedure: Cough Stress Test

Group D

EXPERIMENTAL

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

Interventions

Cough Stress Test PROCEDURE

Varying bladder volumes during cough stress test.

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: August 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share