Soft Tissue Graft for Repair of Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

— POP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827774
• Other study ID #: 12-015
• Status: Completed
• Phase: N/A
• First received: April 3, 2013
• Last updated: February 14, 2018
• Start date: March 2013
• Est. completion date: April 17, 2017

Study information

• Verified date: February 2018
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 17, 2017
• Est. primary completion date: April 17, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Surgisis® Soft Tissue Graft
Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence of pelvic organ prolapse		12 months