Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

Completed

Conditions studied: Pelvic Organ Prolapse (POP)

In brief

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.

Key facts

Study ID

NCT01378065

Run by

Coloplast A/S

People needed

31

Starts

2011-06-01

Expected to finish

2013-09-01

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult female at least 18 years of age
• Willing and able to provide written informed consent
• Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical intervention in the anterior and/or posterior compartment
• Willing and able to complete all follow-up visits and procedures indicated in the protocol

You may not qualify if…

• Concurrent surgical treatment of pelvic organ prolapse using anything other than the Restorelle Direct Fix A\&P
• Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure
• Previous pelvic organ prolapse repair using synthetic grafts
• Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction
• Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction
• Pregnant or a desire to become pregnant
• Previous radiation or other treatments for cancer in the pelvic area
• Immunosuppression and/or current systemic steroid user
• On any anticoagulation therapy at the time of implant or with bleeding diathesis

Where it is running

• MedStar Health Research Institute at Baltimore — Baltimore, Maryland, United States
• Female Pelvic Medicine & Urogynecology Institute of MI — Grand Rapids, Michigan, United States
• Central Missouri Women's Healthcare — Marshall, Missouri, United States
• Center for Pelvic Health — Franklin, Tennessee, United States
• The Group for Women — Norfolk, Virginia, United States
• Integrity Medical Research, LLC — Mountlake Terrace, Washington, United States

Full record on ClinicalTrials.gov

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