Soft Tissue Graft for Repair of Pelvic Organ Prolapse

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT01827774
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-10
• Primary Completion: 2017-04-17
• Study Completion: 2017-04-17
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of recurrence of pelvic organ prolapse	12 months

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China