Pelvic Organ Prolapse
Conditions
Keywords
Pelvic organ prolapse, Graft repair
Brief summary
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.
Interventions
DEVICESurgisis® Soft Tissue Graft
Surgisis® Soft Tissue Graft for pelvic organ prolapse repair
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of recurrence of pelvic organ prolapse | 12 months |
Countries
China
Outcome results
None listed