Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes

Atlantic Health System1 site in 1 country316 target enrollmentJuly 2014

ConditionsPelvic Organ Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Atlantic Health System
Enrollment: 316
Locations: 1
Primary Endpoint: Clinical Cure Rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

August 2015

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Atlantic Health System

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical Cure Rate

Time Frame: 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