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

Study Overview
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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.

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

Conditions
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Anterior Pelvic Organ Prolapse

Intervention / Treatment
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* Device: SIS mesh (Cook Medical)
* Procedure: Anterior prolapse repair


Participation Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIS Mesh (Cook Medical)<br>Anterior prolapse repair will be reinforced using SIS mesh | Device: SIS mesh (Cook Medical)<br>* Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)<br>Procedure: Anterior prolapse repair<br>* Anterior prolapse repair will be conducted without using mesh reinforcement<br>|
| Active Comparator: No-mesh<br>Anterior prolapse repair with no mesh reinforcement | Procedure: Anterior prolapse repair<br>* Anterior prolapse repair will be conducted without using mesh reinforcement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior pelvic organ prolapse, Surgical repair, Pelvic floor surgery, Randomized clinical trial