Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248935
• Other study ID #: 599819-2
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: June 8, 2017
• Start date: July 2014
• Est. completion date: August 2015

Study information

• Verified date: June 2017
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	Department of Urogynecology-Atlantic Health System	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure Rate	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	5-6 years
Secondary	Objective Anatomic Outcome	POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings	5-6 year
Secondary	Mesh exposure/erosion	The rate of mesh exposure or erosion will be measured	5-6 years
Secondary	Complications	any other complications related to the index surgery will be documented	5-6 years
Secondary	Symptom Comparison	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	5-6 years
Secondary	Surgical Satisfaction	The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction	5-6 years