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

Phase 3

Completed

• Conditions: Anterior Pelvic Organ Prolapse
• Interventions: Device: SIS mesh (Cook Medical); Procedure: Anterior prolapse repair

• Registration Number: NCT00955448
• Lead Sponsor: University of Calgary

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Study Start: 2009-12
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIS Mesh (Cook Medical)	SIS mesh (Cook Medical)	Anterior prolapse repair will be reinforced using SIS mesh
SIS Mesh (Cook Medical)	Anterior prolapse repair	Anterior prolapse repair will be reinforced using SIS mesh
No-mesh	Anterior prolapse repair	Anterior prolapse repair with no mesh reinforcement

Primary Outcome Measures

Name	Time	Method
Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)	12 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	12 months postoperatively
Pelvic Floor Distress Inventory short form-20 (PFDI-20)	12 months postoperatively
Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7)	12 months postoperatively
Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)	12 months postoperatively
Surgical complications	Up to 6 weeks postoperatively
Satisfaction with surgical outcome	12 months postoperatively
Change in POP-Q stage from baseline	12 months postoperatively
Change in point Ba (on POP-Q) from baseline	12 months postoperatively
Pelvic Organ Prolapse Quantification(POP-Q) stage	12 months postoperatively

Trial Locations

Locations (1)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada