Safety of vaginal mesh surgery versus laparoscopic mesh sacropexy for cystocele repair: results of the prosthetic pelvic floor repair randomized controlled trial - Lucot, Jean-Philippe; Cosson, Michel; Bader, Georges; Debodinance, Philippe; Akladios, Cherif; Salet-Lizée, Delphine; Delporte, Patrick; Savary, Denis; Ferry, Philippe; Deffieux, Xavier (European urology, 2018)
Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. Objective To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. Design, setting, and participants Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45–75 yr, without previous prolapse surgery. Intervention Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). Outcome measurements and statistical analysis Rate of surgical complications ≥grade II according to the modified Clavien–Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results.
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