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Completed

NCT Number: NCT02248935

Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Sex eligibility

Female

Study type

Observational

Primary location

Department of Urogynecology-Atlantic Health System

Morristown, New Jersey, 07960, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Objective Anatomic Outcome

    Time frame: 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

  2. Mesh exposure/erosion

    Time frame: 5-6 years

    The rate of mesh exposure or erosion will be measured

  3. Complications

    Time frame: 5-6 years

    any other complications related to the index surgery will be documented

  4. Symptom Comparison

    Time frame: 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

  5. Surgical Satisfaction

    Time frame: 5-6 years

    The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2014
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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