Aim: A randomized clinical trial proposing a new laparoscopic prosthetic and fascial approach to severe posterior vaginal prolapse. The primary endpoint was to evaluate the objective and subjective outcomes of our laparoscopic posterior plication (LPP) combined to "two-mesh" sacral colpopexy (laparoscopic sacral colpopexy [LSC]) in severe posterior vaginal prolapse, with a 1-year follow-up. The secondary endpoint was to evaluate the safety of this surgical procedure.Methods: This is single-center prospective randomized double-blinded clinical trial. A total of 130 consecutive patients with anterior and/or apical pelvic organ prolapse (POP) (POP-Q stage ≥II) and severe posterior vaginal prolapse (posterior POP-Q stage ≥III) were prospectively assessed for inclusion into the study from November 2018 to January 2020. Patients underwent "two-meshes" LSC and were randomized in Group A (LSC plus LPP) and Group A (LSC alone). Of the 130 included subjects, 8 were excluded, not meeting inclusion criteria. Cure rate was evaluated objectively, using POP-Q study, and subjectively using PGI-I, POPDI-6, and FSDS questionnaires. Complications were assessed intra-, peri-, and postoperatively. Twelve-month follow-ups were analyzed for the study.Results: We found in LSC plus LPP Group a significant improvement of Ap and genital hiatus POP-Q points. Our subjective study showed, at 12 months, a statistical difference in PGI-I successful outcomes rate in favor of LPP. Also the Neurourol Urodyn.
Importance This article is a long-term follow-up study on the Altis adjustable single incision sling (Coloplast Corp.) in patients with isolated intrinsic sphincteric deficiency (ISD). Objectives The primary end-points were to evaluate the subjective and objective outcomes of the Altis for the treatment of ISD, with a 3-year follow-up. The secondary end-point was to evaluate the safety of this surgical procedure. Study Design This is a retrospective single-arm study. A total of 123 consecutive patients with ISD were selected from our database among women who underwent an Altis implantation for ISD from March 2015 to June 2017, after unsuccessful previous conservative treatment. Of the 123 included patients, 16 were excluded, not meeting inclusion criteria. Cure rate was evaluated objectively, using a standardized cough stress test and urodynamics, and subjectively using the Patient Global Impression of Improvement. Complications were assessed intraoperatively, perioperatively, and postoperatively. Six, 12, and 36months of follow-ups were analyzed for the study. Results The 3-year objective cure rate was 86.9%, and the subjective cure rate was 81.5%. We observed no intraoperative complications. No women were obstructed. Ten patients reported postoperative complications, although most of them were Clavien-Dindo grade I and self-limited. Conclusions Altis system could be considered an effective and safe alternative to traditional midurethral slings as treatment for women with ISD.
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