POP: Soft Tissue Graft for Repair of Pelvic Organ Prolapse

• Sponsor: Cook Group Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01827774
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 49.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Device: Surgisis® Soft Tissue Graft	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Apr 17, 2017
• Actual Study Completion Date: Apr 17, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of recurrence of pelvic organ prolapse [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing		China	100044

Sponsors and Collaborators

• Cook Group Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cook Group Incorporated
• ClinicalTrials.gov Identifier: NCT01827774
• Other Study ID Numbers: 12-015
• First Posted: Apr 10, 2013
• Last Update Posted: Feb 15, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Cook Group Incorporated: Pelvic organ prolapse; Graft repair
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 15, 2018