Raffaele Faioli1, Giulio Sozzi2, Vito Chiantera3, Annamaria Maglione1, Vito Andrea Capozzi4, Pierre Gadonneix5, Delphine Salet-Lizée5, Etienne Vincens5, Michele Meschia6, Richard Villet5. 1. Fondazione IRCCS Casa Sollievo della Sofferenza, Opera di San Pio da Pietrelcina, San Giovanni Rotondo, FG, Italy. 2. Department of Gynecologic Oncology, University of Palermo, Palermo, Italy. Electronic address: giuliosozzi@hotmail.it. 3. Department of Gynecologic Oncology, University of Palermo, Palermo, Italy. 4. Department of Obstetrics and Gynecology, University of Parma, Parma, Italy. 5. Department of Visceral and Gynecologic Surgery, Diaconesses Hospital, Paris, France. 6. Department of Obstetrics and Gynecologic Surgery, G. Fornaroli Hospital, Magenta, MI, Italy.
Abstract
OBJECTIVE: Pelvic organ prolapse is a common condition among post-menopausal women, and surgery is often the standard treatment proposed. Native tissue vaginal surgery is burdened by a high rate of recurrence, and mesh vaginal surgery has become current practice. The purpose of this study was to evaluate the safety and the effectiveness of the vaginal kit Anterior/Apical single incision mesh Elevate™ for the correction of anterior and apical compartment prolapse. STUDY DESIGN: Data of patients with symptomatic anterior vaginal prolapse stage ≥ II, receiving mesh repair with the Anterior/Apical Elevate single incision system between January 2010 and January 2015 were retrieved. Prolapse was classified according to the POP-Q system. The main outcome measure was anatomical success, while subjective and safety outcomes were secondary outcomes. RESULTS: Anatomical success rate was 87.2 % for anterior compartment prolapse and 84.6 % for combined anterior and apical prolapse, while overall functional success rate was 96.2 % after a median follow-up of 33.6 months. The most frequent short-term complications were urinary bladder injury (3.0 %) and transient urinary retention (6.9 %). The most common long-term complications were de novo or persistent symptomatic stress urinary incontinence (10.8 %) and vaginal mesh extrusion (3.8 %). CONCLUSION: Mesh vaginal surgery with Anterior/Apical single incision mesh Elevate™ is a well-tolerated procedure with a very high anatomical and functional success rate. Short and long-term complications rate seem to be acceptable, and in most of cases, solvable. Further studies are needed to confirm our promising data.
OBJECTIVE: Pelvic organ prolapse is a common condition among post-menopausal women, and surgery is often the standard treatment proposed. Native tissue vaginal surgery is burdened by a high rate of recurrence, and mesh vaginal surgery has become current practice. The purpose of this study was to evaluate the safety and the effectiveness of the vaginal kit Anterior/Apical single incision mesh Elevate™ for the correction of anterior and apical compartment prolapse. STUDY DESIGN: Data of patients with symptomatic anterior vaginal prolapse stage ≥ II, receiving mesh repair with the Anterior/Apical Elevate single incision system between January 2010 and January 2015 were retrieved. Prolapse was classified according to the POP-Q system. The main outcome measure was anatomical success, while subjective and safety outcomes were secondary outcomes. RESULTS: Anatomical success rate was 87.2 % for anterior compartment prolapse and 84.6 % for combined anterior and apical prolapse, while overall functional success rate was 96.2 % after a median follow-up of 33.6 months. The most frequent short-term complications were urinary bladder injury (3.0 %) and transient urinary retention (6.9 %). The most common long-term complications were de novo or persistent symptomatic stress urinary incontinence (10.8 %) and vaginal mesh extrusion (3.8 %). CONCLUSION: Mesh vaginal surgery with Anterior/Apical single incision mesh Elevate™ is a well-tolerated procedure with a very high anatomical and functional success rate. Short and long-term complications rate seem to be acceptable, and in most of cases, solvable. Further studies are needed to confirm our promising data.