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

A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Surgisis® Soft Tissue Graft

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgisis® Soft Tissue Graft	Device: Surgisis® Soft Tissue Graft; Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of recurrence of pelvic organ prolapse	12 months

Collaborators and Investigators

• Sponsor: Cook Group Incorporated

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 17, 2017
• Study Completion (Actual): April 17, 2017

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; Graft repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 12-015