Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

Completed

• Conditions: Stress Urinary Incontinence (SUI)

• Registration Number: NCT01982188
• Lead Sponsor: Atlantic Health System

Brief Summary

This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period

Exclusion Criteria

• previous surgical treatment for stress urinary incontinence (SUI)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cough Stress Test	12 months post procedure	Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.

Secondary Outcome Measures

Name	Time	Method
Urinary Impact Questionnaire (UIQ-7)	baseline and 12 months postoperatively	this validated questionnaire will be completed by subject to collect subjective data
Sandvick Severity Index Questionnaire	baseline and 12 months postoperatively	This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence
mesh related complications	12 months post procedure	possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period
Urinary Distress Inventory 6 (UDI-6)	baseline and 12 months postoperatively	This validated questionnaires will be given to subject to collect subjective data

Trial Locations

Locations (1)

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States