Restorelle® Mesh Versus Native Tissue Repair for Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Device: Restorelle Direct Fix AProcedure: Native Tissue Repair AnteriorProcedure: Native Tissue Repair PosteriorDevice: Restorelle Direct Fix P
- Registration Number
- NCT02162615
- Lead Sponsor
- Coloplast A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 810
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Restorelle Direct Fix A Restorelle Direct Fix A Anterior/Apical prolapse repair with Restorelle Direct Fix A Native Tissue Repair Anterior Native Tissue Repair Anterior Anterior/Apical prolapse repair with native tissue only Native Tissue Repair Posterior Native Tissue Repair Posterior Posterior/Apical prolapse repair with native tissue only Restorelle Direct Fix P Restorelle Direct Fix P Posterior/Apical prolapse repair with Restorelle Direct Fix P
- Primary Outcome Measures
Name Time Method Rate of device and procedure related serious adverse events 12 Month Recurrence of Prolapse 12 Month Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
- Secondary Outcome Measures
Name Time Method Recurrence of Prolapse 36 Month Recurrent Prolapse measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Device or Procedure related AEs of interest 36 months
Trial Locations
- Locations (48)
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Akron Urogynecology Associates
🇺🇸Akron, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
🇺🇸Allentown, Pennsylvania, United States
Wellspan Urogynecology and Pelvic Reconstructive Surgery
🇺🇸York, Pennsylvania, United States
Scott D. Lauer, DO, PA
🇺🇸Colleyville, Texas, United States
SurgOne Pelvic Solutions Center
🇺🇸Denver, Colorado, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Andrew Shapiro
🇺🇸Owings Mills, Maryland, 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, District of Columbia, United States
Baystate Health System
🇺🇸Springfield, Massachusetts, United States
Women's Pelvic Health and Continence Center
🇺🇸Hamlet, North Carolina, United States
Stanford University
🇺🇸Stanford, California, United States
CHRU Lille
🇫🇷Lille, France
Female Pelvic Medicine & Urogynecology Institute of MI
🇺🇸Grand Rapids, Michigan, United States
The Group for Women
🇺🇸Norfolk, Virginia, United States
Hôpital Maisonneuve-Rosemount
🇨🇦Montreal, Quebec, Canada
Swan Urogynecology
🇺🇸Nashville, Tennessee, United States
UZ Leuven
🇧🇪Leuven, Belgium
Mater Pelvic Health
🇦🇺Pimlico, Queensland, Australia
Center for Women's Health of Lansdale
🇺🇸Lansdale, Pennsylvania, United States
Centre for Advanced Reproductive Endosurgery
🇦🇺St Leonards, New South Wales, Australia
Integrity Medical Research
🇺🇸Mountlake Terrace, Washington, United States
Carilion Clinic New River Valley
🇺🇸Christiansburg, Virginia, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
CHUS-CRC
🇨🇦Sherbrooke, Quebec, Canada
Amphia Hospital
🇳🇱Breda, Netherlands
CHU Nimes
🇫🇷Nimes, France
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands
Maastricht UMC
🇳🇱Maastricht, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Bergman Clinics
🇳🇱Bilthoven, Netherlands
AMC Medical Center
🇳🇱Amsterdam, Netherlands
ISALA
🇳🇱Zwolle, Netherlands
Premier Medical Group of Hudson Valley, PC
🇺🇸Poughkeepsie, New York, United States
Novant Health Urogynecology
🇺🇸Charlotte, North Carolina, United States
The Female Pelvic Health Center
🇺🇸Newtown, Pennsylvania, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Sherry Thomas, M.D.
🇺🇸Agoura Hills, California, United States
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Sanford Research
🇺🇸Sioux Falls, South Dakota, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Adult & Pediatric Urology, PC
🇺🇸Omaha, Nebraska, United States
Montefiore Medical Research Center
🇺🇸Bronx, New York, United States
Novant Health Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Central Texas Urogynecology and Continence Center
🇺🇸Austin, Texas, United States