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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anterior Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SIS Mesh (Cook Medical)

Anterior prolapse repair will be reinforced using SIS mesh

Group Type EXPERIMENTAL

SIS mesh (Cook Medical)

Intervention Type DEVICE

Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)

Anterior prolapse repair

Intervention Type PROCEDURE

Anterior prolapse repair will be conducted without using mesh reinforcement

No-mesh

Anterior prolapse repair with no mesh reinforcement

Group Type ACTIVE_COMPARATOR

Anterior prolapse repair

Intervention Type PROCEDURE

Anterior prolapse repair will be conducted without using mesh reinforcement

Interventions

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SIS mesh (Cook Medical)

Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)

Intervention Type DEVICE

Anterior prolapse repair

Anterior prolapse repair will be conducted without using mesh reinforcement

Intervention Type PROCEDURE

Eligibility Criteria

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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 study.

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No