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

Not Applicable

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: Cough Test following Sling Surgery

• Registration Number: NCT03120117
• Lead Sponsor: Michigan Institution of Women's Health PC

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-08
• Status Verified: 2017-04
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cough Test following Sling Surgery	Cough Test following Sling Surgery	All subjects enrolled will undergo sling surgery for treatment of stress urinary incontinence and subsequently asked to do a standing cough test.

Primary Outcome Measures

Name	Time	Method
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire.	Within first two years following sling procedure	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.
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test.	Within first two years following sling procedure	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.

Trial Locations

Locations (1)

Advanced Urogynecology of Michigan, P.C.; 🇺🇸 Dearborn, Michigan, United States