OBJECTIVE: To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse (POP) surgery using a repair augmented with porcine small intestine submucosa mesh (Mesh Group) compared with those who had a native tissue repair (No Mesh Group).
METHODS: This was a randomized controlled trial with 12 months follow-up. The surgical procedure was identical in both groups except for the placement of intervening mesh. The primary outcome was anatomical “cure” (Ba of −1 or less on Pelvic Organ Prolapse Quantification [POP-Q]). Secondary outcomes included POP-Q stage, patient-reported outcomes, and patient satisfaction. The study was powered to detect a 40% difference at 80% power (α=0.05).
RESULTS: Fifty-seven women were randomized (28 to Mesh Group, 29 to No Mesh Group). Forty-five (79%) underwent concomitant surgery. At the 12-month follow-up, 56% (15/27) in the Mesh Group and 61% (17/28) in the No Mesh Group were considered cured (relative risk 0.90, 95% confidence interval 0.52–1.54). There were no significant differences between groups in recurrent or persistent prolapse (7% in each group) nor in patient-reported outcomes at 12 months. Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group.
CONCLUSION: No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair. In our study, porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT0095544.
LEVEL OF EVEDIENCE: I
No outcome differences are found after 12 months in an anterior compartment prolapse randomized trial comparing small intestine submucosa mesh augmentation with native tissue repair.
Departments of Obstetrics and Gynecology, University of Calgary, Calgary, and University of Edmonton, Edmonton, Alberta, and University of Sherbrooke, Sherbrooke, Quebec, Canada.
Corresponding author: Magali Robert, MD, MSc, Department of Obstetrics and Gynecology, University of Calgary, 4th Floor, North Tower, Foothills Medical Centre, 1403-29th Street, Calgary, Alberta T2N 2T9, Canada; e-mail: email@example.com.
Supported by Cook Medical, which provided grant-in-aid funding for the study.
Financial Disclosure Dr. Robert has served on the advisory committee for Cook Myosite and is the Fellowship Director for a fellowship program funded by Cook Medical. Dr. Brennand completed fellowship sponsored by Cook Medical. Dr. Ross accepted grant-in-aid funding from Johnson & Johnson Medical Companies, Boston Scientific, and Cook Surgical. The other authors did not report any potential conflicts of interest.