Composite Outcomes of MEsh vs suture Techniques for prolapse repair: A randomized controlled multicentre trial
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 fecal leakage and pelvic organ prolapse (bulging of pelvic organs through the vaginal opening). These problems usually come together and are very common, affecting approximately 1 in 3 women. They affect women’s ability to lead normal lives, be physically active and enjoy normal sexual relations. Surgery is a treatment option for women with pelvic floor problems.
In 2016, Dr. Roxana Geoffrion was awarded a Canadian Institutes for Health Research (CIHR) project scheme grant to investigate two different surgeries for vaginal repair of prolapse (small mesh arms versus permanent sutures) to determine which surgery may be more durable. There are many different ways to fix the top of the vagina. Traditionally, the top of the vagina is connected to ligaments behind the vagina called sacrospinous ligaments. Dr. Roxana Geoffrion developed a surgical technique which attempts to fix pelvic organ prolapse symptoms by attaching the top of the vagina to sacrospinous ligaments via permanent synthetic mesh arms. This is performed via a vaginal approach, which is considered minimally invasive. Dr. Geoffrion has ten years of experience perfecting this technique. She has also demonstrated that this technique is safe and successful in the first year after surgery.
COMET: Composite Outcomes of Mesh vs suture Techniques for prolapse repair is the first CIHR-funded trial in pelvic reconstructive surgery in Canada. It has made great strides to encourage collaborations from urogynecologists across BC and Canada; collaborators include Dr. Darren Lazare (Fraser Health), Dr. Geoffrey Cundiff (UBC), Dr. Fariba Mohtashami (Fraser Health), Dr. Chelsea Elwood (UBC), Dr. Momoe Hyakutake (University of Alberta), Dr. Erik-Jens Walter (McGill University) and Dr. Maryse Larouche (McGill University). Co-investigators include Dr. Joel Singer, Dr. Lori Brotto and Dr. Wei Zhang.
In addition to finding the best surgical approach to treat pelvic floor disorders, this study also aims to bring awareness to pelvic floor disorders and the debilitating effects they can pose on women’s everyday lives. Women in this study will be randomly assigned to one of the two surgeries and followed for up to two years. Recruitment will take place across multiple sites and, in total, 358 women will hopefully participate and follow up for two years after their surgery. The trial looks at women’s opinion of how the surgery worked to alleviate prolapse and other pelvic symptoms. Results of a pelvic exam and self-reported measures of sexual function will also be collected. We hope to solve the controversy about vaginal mesh for prolapse and provide an alternative that may be a better, more durable, surgical treatment option for women with prolapse.
Since patient education is of crucial importance, we have developed a knowledge translation plan to educate the general public and our patients about highly prevalent pelvic floor disorders. The trial will be developing a community advisory group to help disseminate key findings to various stakeholders. Social media platforms such as Facebook, Twitter and YouTube will be used to establish a strong online presence.
This study is currently open to recruitment.
For more information about the study please contact:
Nikki Koenig – Research Coordinator/Research Manager