Status:
COMPLETED
Soft Tissue Graft for Repair of Pelvic Organ Prolapse
Lead Sponsor:
Cook Group Incorporated
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01827774
Start Date
March 1 2013
End Date
April 17 2017
Last Update
February 15 2018
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100044