Overview

This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatment surgisis® soft tissue graft
Sponsor Cook
Start date March 2013
End date January 2017
Trial size 31 participants
Trial identifier NCT01827774, 12-015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
surgisis® soft tissue graft
Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

Primary Outcomes

Measure
Rate of recurrence of pelvic organ prolapse
time frame: 12 months

Eligibility Criteria

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

Additional Information

Official title A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cook.