Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Completed

Conditions studied: Pelvic Organ Prolapse

In brief

The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.

Key facts

Study ID

NCT02162615

Run by

Coloplast A/S

People needed

810

Starts

2014-08-01

Expected to finish

2021-11-06

Last updated by the study team

2022-01-27

Who can join

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

You may qualify if…

• Female at least 18 years of age
• Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl
• Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
• Subject is willing to provide written informed consent
• Subject is willing and able to comply with the follow-up regimen

You may not qualify if…

• Subject is pregnant or intends to become pregnant during the study
• Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
• Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
• Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
• Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
• Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
• Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
• Subject has uncontrolled diabetes mellitus (DM)
• Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
• Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
• Subject is not able to conform to the modified dorsal lithotomy position
• Subject is currently participating in or plans to participate in another device or drug study during this study
• Subject has a known sensitivity to polypropylene
• Subject has had previous prolapse repair with mesh in the target compartment(s)
• Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue repair

Where it is running

• Sherry Thomas, M.D. — Agoura Hills, California, United States
• Stanford University — Stanford, California, United States
• SurgOne Pelvic Solutions Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Center for Urogynecology and Pelvic Surgery, Christiana Care Health System — Newark, Delaware, United States
• MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery — Washington D.C., District of Columbia, United States
• Rosemark Women Care Specialists — Idaho Falls, Idaho, United States
• Andrew Shapiro — Owings Mills, Maryland, United States
• Baystate Health System — Springfield, Massachusetts, United States
• Female Pelvic Medicine & Urogynecology Institute of MI — Grand Rapids, Michigan, United States
• Beyer Research — Kalamazoo, Michigan, United States
• Adult & Pediatric Urology, PC — Omaha, Nebraska, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Atlantic Health System — Morristown, New Jersey, United States
• Premier Medical Group of Hudson Valley, PC — Poughkeepsie, New York, United States
• Montefiore Medical Research Center — The Bronx, New York, United States
• Novant Health Urogynecology — Charlotte, North Carolina, United States
• Women's Pelvic Health and Continence Center — Hamlet, North Carolina, United States
• Novant Health Clinical Research — Winston-Salem, North Carolina, United States
• Akron Urogynecology Associates — Akron, Ohio, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• The Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
• Center for Women's Health of Lansdale — Lansdale, Pennsylvania, United States
• The Female Pelvic Health Center — Newtown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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