Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures

Study Overview
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Brief Summary
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This is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.

Detailed Description
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The goal is to seek correlation or disparity between the supine versus the sitting cough test, supine (lying down) versus standing cough test and sitting versus the standing cough test performed at a constant bladder volume; empty in the office and full in the operating room. Secondary objective is to test if the intra-operative standing cough test at fullness correlates with long term success of the sling surgery.

Official Title
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Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Cough Test following Sling Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who present with stress-dominant urinary incontinence Patients who have undergone a stress test documentation both in the supine and standing/sitting position. Patients who have completed child bearing. Patients between 21 and 89 years of age. Exclusion Criteria: Patients who do not agree to participate and do not sign the informed consent. Patients undergoing concomitant surgery Patients undergoing surgery under anesthesia.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cough Test following Sling Surgery<br>All subjects enrolled will undergo sling surgery for treatment of stress urinary incontinence and subsequently asked to do a standing cough test. | Procedure: Cough Test following Sling Surgery<br>* Enrolled subjects will undergo sling surgery who present with stress-dominated urinary incontinence. While in the operating room, the subject will be asked to stand and cough to determine if there is still leakage once the sling has been placed.<br>* Other names: DISST Procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test. | Success criteria will be defined through the examination of patient's post-operative visits regarding cough stress tests in supine, sitting and standing positions where the bladder is at 10% of urodynamic fullness. Failure to meet this criteria will be considered recurrence of stress incontinence. | Within first two years following sling procedure | 
| Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire. | Success criteria is also defined through the examination of patient's response to Medical Epidemiologic and Social Aspects of Aging 12 (MESA) to determine recurrence of stress incontinence. Failure to meet this criteria will be considered recurrence of stress incontinence. | Within first two years following sling procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midurethral Slings