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

Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Anterior Pelvic Organ Prolapse
• Intervention / Treatment: Device: SIS mesh (Cook Medical); Procedure: Anterior prolapse repair

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1C5
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SIS Mesh (Cook Medical); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Change in point Ba (on POP-Q) from baseline	12 months postoperatively
Pelvic Organ Prolapse Quantification(POP-Q) stage	12 months postoperatively
Change in POP-Q stage from baseline	12 months postoperatively
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services; Cook Group Incorporated

Publications and helpful links

General Publications

• Robert M, Girard I, Brennand E, Tang S, Birch C, Murphy M, Ross S. Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):288-294. doi: 10.1097/AOG.0000000000000105.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 7, 2009
• First Posted (ESTIMATE): August 10, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Surgical repair; Anterior pelvic organ prolapse; Pelvic floor surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Anterior SIS 300609; Ethics: E-22217