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Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study (Anterior SIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cook
Alberta Health Services
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00955448
First received: August 5, 2009
Last updated: December 22, 2011
Last verified: August 2011
History of Changes
  Purpose

Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.

One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.

Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.


Condition Intervention Phase
Anterior Pelvic Organ Prolapse
 Device: SIS mesh (Cook Medical)
Procedure: Anterior prolapse repair
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative) [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in point Ba (on POP-Q) from baseline [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Pelvic Organ Prolapse Quantification(POP-Q) stage [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Change in POP-Q stage from baseline [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: Yes ]
  • Pelvic Floor DIstress Inventory short form-20 (PFDI-20) [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7) [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: Yes ]
  • Surgical complications [ Time Frame: Up to 6 weeks postoperatively ] [ Designated as safety issue: Yes ]
  • Satisfaction with surgical outcome [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIS Mesh
Anterior prolapse repair will be reinforced using SIS mesh
 Device: SIS mesh (Cook Medical)
Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)
Procedure: Anterior prolapse repair
Anterior prolapse repair will be conducted without using mesh reinforcement
Active Comparator: No-mesh
Anterior prolapse repair with no mesh reinforcement
 Procedure: Anterior prolapse repair
Anterior prolapse repair will be conducted without using mesh reinforcement

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
  • Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
  • Patient must consent to participate in the RCT.

Exclusion Criteria:

  • Having an obliterative procedure (Lefort procedure or colpocleisis).
  • Allergy to graft material.
  • Immunocompromised.
  • Previous anterior compartment repair.
  • Are unable to understand English.
  • Will be unavailable for follow-up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955448

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 1C5
Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y 6J4
Sponsors and Collaborators
University of Calgary
Cook
Alberta Health Services
Investigators
Principal Investigator: Magali Robert, MD University of Calgary
  More Information

No publications provided

Responsible Party: Dr Magali Robert, University of Calgary
ClinicalTrials.gov Identifier: NCT00955448     History of Changes
Other Study ID Numbers: Anterior SIS 300609, Ethics: E-22217
Study First Received: August 5, 2009
Last Updated: December 22, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Anterior pelvic organ prolapse
Surgical repair
Pelvic floor surgery
Randomized clinical trial

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

ClinicalTrials.gov processed this record on June 18, 2013