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Grant: Project Grant

University of British Columbia

$573,375.00

Vaginal Surgery for the Pelvic Floor: A Randomized Trial of Synthetic Mesh Versus Synthetic Sutures

FY 2015-16

Summary
More than 4 million women in Canada suffer from pelvic floor diseases. Pelvic floor muscles, nerves and ligaments can tear and stretch, mainly from vaginal deliveries of babies and aging. Women experience urine or stool leakage and pelvic organ prolapse or bulging of pelvic organs through the vaginal opening. These problems usually come together and are very common. They affect women's ability to lead normal lives, be physically active and enjoy normal sexual relations. Many become depressed and isolated. Surgery for prolapse often fails and symptoms come back. Surgeons thought that plastic permanent mesh behind the vagina would offer a more durable repair. Unfortunately, mesh kits were commercialized without much study. They caused many unexpected complications of pain, discharge, exposure of the mesh to the surface of the vagina, and did not cure prolapse. Most were taken off the market. Women who currently want vaginal surgical repair have the option of permanent sutures to hold the vaginal wall in place. This technique is not perfect because it can tension the vagina too much and can still cause pain and return of prolapse. We know, from successful surgeries with slings for urine incontinence, and from other small studies, that vaginal mesh is safe if introduced in small amounts, deep in the pelvis, without tension. Therefore, we propose to study 2 surgeries for vaginal repair of prolapse, using small mesh arms versus permanent sutures. We think that surgery with mesh may be more durable than surgery with sutures, but we cannot know for sure until we perform our study. Women will be randomly assigned to one of the two surgeries and followed for 2 years. We will study women's opinion of how the surgery worked for their prolapse, their other pelvic symptoms, pelvic exam and their sexual health. We hope to solve the controversy about vaginal mesh for prolapse and investigate a new procedure that may be a better, more durable option for women with prolapse.
Program
Project Grant
Location
British Columbia, Canada
Recipient Type
Academia
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
345409
Name
Geoffrion Roxana
Region
British Columbia
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Aging
Theme2
Clinical
Prcname2
Project Grant Competition
Projecttitle
Vaginal Surgery for the Pelvic Floor: A Randomized Trial of Synthetic Mesh Versus Synthetic Sutures
Programtype2
Operating Grants
Orgnameinp2
University of British Columbia
Cihramount2
$573,375
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Body Image; Health Economics; Long Term Clinical Follow Up; Pelvic Floor Dysfunction; Pelvic Organ Prolapse; Randomized Controlled Trial; Sexual Health; Synthetic Mesh; Synthetic Sutures; Vaginal Surgery
Abstract
More than 4 million women in Canada suffer from pelvic floor diseases. Pelvic floor muscles, nerves and ligaments can tear and stretch, mainly from vaginal deliveries of babies and aging. Women experience urine or stool leakage and pelvic organ prolapse or bulging of pelvic organs through the vaginal opening. These problems usually come together and are very common. They affect women's ability to lead normal lives, be physically active and enjoy normal sexual relations. Many become depressed and isolated. Surgery for prolapse often fails and symptoms come back. Surgeons thought that plastic permanent mesh behind the vagina would offer a more durable repair. Unfortunately, mesh kits were commercialized without much study. They caused many unexpected complications of pain, discharge, exposure of the mesh to the surface of the vagina, and did not cure prolapse. Most were taken off the market. Women who currently want vaginal surgical repair have the option of permanent sutures to hold the vaginal wall in place. This technique is not perfect because it can tension the vagina too much and can still cause pain and return of prolapse. We know, from successful surgeries with slings for urine incontinence, and from other small studies, that vaginal mesh is safe if introduced in small amounts, deep in the pelvis, without tension. Therefore, we propose to study 2 surgeries for vaginal repair of prolapse, using small mesh arms versus permanent sutures. We think that surgery with mesh may be more durable than surgery with sutures, but we cannot know for sure until we perform our study. Women will be randomly assigned to one of the two surgeries and followed for 2 years. We will study women's opinion of how the surgery worked for their prolapse, their other pelvic symptoms, pelvic exam and their sexual health. We hope to solve the controversy about vaginal mesh for prolapse and investigate a new procedure that may be a better, more durable option for women with prolapse.
Competitiondate
201603
Approvedterm2
5 yrs 0 mth
Pinamesdelim
Geoffrion, Roxana
Approvedterm
5 ans 0 mois
Cihrcontribution2
~ $573,375~ $0~