Efficacy and safety of Elevate® system on apical and anterior compartment prolapse repair with personal technique modification

Vol. 43 (6): 1115-1121, November – December, 2017

doi: 10.1590/S1677-5538.IBJU.2016.0233


ORIGINAL ARTICLE

Daniele Castellani 1, Vikiela Galica 1, Pietro Saldutto 1, Giuseppe Paradiso Galatioto 1, Carlo Vicentini 1
1 Department of Life, Health & Environmental Sciences, University of L’Aquila, Urology Unit, “Giuseppe Mazzini” Hospital, Teramo, Italy

ABSTRACT

Aim: To evaluate the effectiveness and safety of Anterior Elevate® mesh kit system (AES) in woman with symptomatic stage 3 or 4 anterior and/or apical pelvic organ prolapse (POP).
Materials and Methods: This retrospective, monocentric, single surgeon study enrolled between May 2010 and January 2013 fifty-six woman experiencing symptomatic an¬terior vaginal prolapse with or without apical descent (POP-Q stage 3 or 4). All women received a AES and 7 (12.5%) received a concomitant transvaginal hysterectomy. Pri¬mary endpoint was anatomic correction of prolapse; success was defined as POP-Q stage ≤ 1 or asymptomatic stage 2. Secondary endpoints were quality-of-life (QOL) re¬sults and patients’ safety outcomes, which were assessed by 3 validated self-reporting questionnaires at baseline and annually: ICIQ-UI short form, ICIQ-VS and P-QOL. All patients completed 2-years and 28 women 3-years of follow-up. Surgical approach was modified in women with uterus, moving the two-propylene strips anteriorly around the cervix itself crossing one another, so the left will take place in the right side and the right on the opposite. This modification was made in order to better support the uterus.
Results: Vaginal mesh exposure was present in 3 (5,3%) patients. Very good anatomi¬cal outcomes were seen, with one (1,8%) failure at 6-months, 4 (7,1%) at 1-year, 6 at 2-years (10,7%). Statistically significant improvements were seen in the ICIQ-VS and P-QOL questionnaires throughout follow-up.
Conclusion: Our data suggest that AES is a minimally-invasive transvaginal procedure to repair anterior and apical POP, with good evidence related to mid-term safety and efficacy.

Keywords:  Pelvic Organ Prolapse; Surgical Mesh; Vagina; Surgical Procedures, Operative

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