Restorelle® Mesh Versus Native Tissue Repair for Prolapse
- Conditions
- Pelvic Organ Prolapse
- 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
- 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)
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, 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
Scroll for more (38 remaining)Sherry Thomas, M.D.🇺🇸Agoura Hills, California, United States