Soft Tissue Graft for Repair of Pelvic Organ Prolapse
This trial has been completed.
|Condition||pelvic organ prolapse|
|Treatment||surgisis® soft tissue graft|
|Start date||March 2013|
|End date||March 2017|
|Trial size||31 participants|
|Trial identifier||NCT01827774, 12-015|
The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.
|Intervention model||single group assignment|
Rate of recurrence of pelvic organ prolapse
time frame: 12 months
Female participants at least 18 years old.
Inclusion Criteria: - Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse. - POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse) - At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia) Exclusion Criteria: - Age < 18 years - BMI > 40 - Not medically fit for transvaginal surgery under general or spinal anesthesia - Active UTI at the time of the index procedure as determined by urine culture - Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.) - Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse - A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer - Currently planned obliterative surgical repair for pelvic organ prolapse - Systemic infection at the time of surgery - Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents - Pregnant, breastfeeding or planning pregnancy during the study period - Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos) - Physical allergies or cultural objections to the receipt of porcine products - Life expectancy of less than 12 months - Ongoing participation in an investigational device or drug trial - Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome) - Active vaginal infection at the time of the index procedure - History of pelvic inflammatory disease
|Official title||A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse|
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