Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT02248935
• Lead Sponsor: Atlantic Health System

Brief Summary

The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 316

Inclusion Criteria

• All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh

Exclusion Criteria

• Refusal to participate in our long-term outcome study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Cure Rate	5-6 years	To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire

Secondary Outcome Measures

Name	Time	Method
Mesh exposure/erosion	5-6 years	The rate of mesh exposure or erosion will be measured
Surgical Satisfaction	5-6 years	The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction
Objective Anatomic Outcome	5-6 year	POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings
Symptom Comparison	5-6 years	to compare related symptoms such as urinary frequency, bowel function, and sexual function both between mesh groups and for the entire group compared to 12 month findings
Complications	5-6 years	any other complications related to the index surgery will be documented

Trial Locations

Locations (1)

Department of Urogynecology-Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States