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

NCT00955448 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2016-08-31

No results posted yet for this study

Summary

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.

Conditions

  • Anterior Pelvic Organ Prolapse

Interventions

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

Sponsors & Collaborators

  • Cook Group Incorporated

    collaborator INDUSTRY

  • Alberta Health services

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Magali Robert, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00955448 on ClinicalTrials.gov