Soft Tissue Graft for Repair of Pelvic Organ Prolapse (POP)

Cook Group

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Device: Surgisis® Soft Tissue Graft

Study type

Interventional

Funder types

Industry

Identifiers

NCT01827774

12-015

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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