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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827774
First Posted: April 10, 2013
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
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 Intervention
Pelvic Organ Prolapse Device: Surgisis® Soft Tissue Graft

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • Rate of recurrence of pelvic organ prolapse [ Time Frame: 12 months ]

Enrollment: 31
Study Start Date: March 2013
Study Completion Date: March 21, 2017
Primary Completion Date: March 21, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgisis® Soft Tissue Graft Device: Surgisis® Soft Tissue Graft
Surgisis® Soft Tissue Graft for pelvic organ prolapse repair

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827774


Locations
China
Peking University People's Hospital
Beijing, China, 100044
Sponsors and Collaborators
Cook Group Incorporated
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01827774     History of Changes
Other Study ID Numbers: 12-015
First Submitted: April 3, 2013
First Posted: April 10, 2013
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Cook Group Incorporated:
Pelvic organ prolapse
Graft repair

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical