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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics: E-22217 |
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| Name | Class |
|---|---|
| Cook Group Incorporated | INDUSTRY |
| Alberta Health services | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIS Mesh (Cook Medical) | Experimental | Anterior prolapse repair will be reinforced using SIS mesh |
|
| No-mesh | Active Comparator | Anterior prolapse repair with no mesh reinforcement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIS mesh (Cook Medical) | Device | Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magali Robert, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24402595 | Result | 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. |
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| Anterior prolapse repair | Procedure | Anterior prolapse repair will be conducted without using mesh reinforcement |
|
| 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 |