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

Primary Purpose

Anterior Pelvic Organ Prolapse

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
SIS mesh (Cook Medical)
Anterior prolapse repair
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Pelvic Organ Prolapse focused on measuring Anterior pelvic organ prolapse, Surgical repair, Pelvic floor surgery, Randomized clinical trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Foothills Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SIS Mesh (Cook Medical)

No-mesh

Arm Description

Anterior prolapse repair will be reinforced using SIS mesh

Anterior prolapse repair with no mesh reinforcement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2009
Last Updated
August 29, 2016
Sponsor
University of Calgary
Collaborators
Cook Group Incorporated, Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT00955448
Brief Title
Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study
Acronym
Anterior SIS
Official Title
Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Cook Group Incorporated, Alberta Health services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Pelvic Organ Prolapse
Keywords
Anterior pelvic organ prolapse, Surgical repair, Pelvic floor surgery, Randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIS Mesh (Cook Medical)
Arm Type
Experimental
Arm Description
Anterior prolapse repair will be reinforced using SIS mesh
Arm Title
No-mesh
Arm Type
Active Comparator
Arm Description
Anterior prolapse repair with no mesh reinforcement
Intervention Type
Device
Intervention Name(s)
SIS mesh (Cook Medical)
Intervention Description
Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)
Intervention Type
Procedure
Intervention Name(s)
Anterior prolapse repair
Intervention Description
Anterior prolapse repair will be conducted without using mesh reinforcement
Primary Outcome Measure Information:
Title
Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
Change in point Ba (on POP-Q) from baseline
Time Frame
12 months postoperatively
Title
Pelvic Organ Prolapse Quantification(POP-Q) stage
Time Frame
12 months postoperatively
Title
Change in POP-Q stage from baseline
Time Frame
12 months postoperatively
Title
Postoperative complications
Time Frame
12 months postoperatively
Title
Pelvic Floor Distress Inventory short form-20 (PFDI-20)
Time Frame
12 months postoperatively
Title
Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7)
Time Frame
12 months postoperatively
Title
Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Time Frame
12 months postoperatively
Title
Surgical complications
Time Frame
Up to 6 weeks postoperatively
Title
Satisfaction with surgical outcome
Time Frame
12 months postoperatively

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magali Robert, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24402595
Citation
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.
Results Reference
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Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study

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