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

Coloplast

Status: Completed

Conditions: Pelvic Organ Prolapse (POP)

Treatments: Device: Restorelle Direct Fix A&P

Study type: Observational

Funder types: Industry

Identifiers

NCT01378065

US011

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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