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

Castellani, Daniele; Galica, Vikiela; Saldutto, Pietro; Galatioto, Giuseppe Paradiso; Vicentini, Carlo

doi:10.1590/s1677-5538.ibju.2016.0233

Cited by 6 publications

(4 citation statements)

References 26 publications

(32 reference statements)

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“…In the MESH group, protrusions occurred, namely 3 (6 %) at 1-year follow-up and 4 (8 %) at 3-year follow-up. These results are comparable with the results of other studies that used synthetic material (10,11,26,27). In both sets, there was a conformity with other studies (28)(29)(30), namely in the signifi cant disappearance of OAB symptoms (MESH 73 % vs ASCCF 62 %); the difference, however, was not statistically signifi cant.…”

Section: Discussionsupporting

confidence: 89%

“…In our prospective study, we showed that the effectiveness of the correction of the anterior compartment determined at 1-year and 3-year follow-ups was higher in the MESH group (point Ba: 92 % and 87 %, respectively) in comparison with ACSSF group (point Ba: 70 % and 66 %, respectively). Our results are comparable with those of other studies comparing the effectiveness of correction by use of the synthetic material Elevate anterior or NUVIA SI anterior (10)(11)(12)(13).…”

Section: Discussionsupporting

confidence: 89%

See 1 more Smart Citation

Single‑incision mesh vs sacrospinous ligament fixation in posthysterectomy women at a three-year follow-up: a randomized trial

Galad¹,

Papcun²,

Dudič³

et al. 2020

BLL

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OBJECTIVES: The primary clinical objective was to prospectively compare the effectiveness of the "single-incision MESH" technique versus sacrospinous ligament fi xation (ACSSF) in correcting the defect of pelvic organ prolapse (POP) in the anterior and apical compartments, Their effectiveness was assessed at a 1-year/3-year follow-up (FU). METHODS: In the period of 2013-2015, we have randomized 146 women into two groups, namely 73 into ACSSF group and 73 into MESH group RESULTS: At 1-year/3-year FU, we achieved an effectiveness of 92 %/87 % in the point Ba (≤ -1 cm) in the MESH group (48/52; 40/46) vs 70 %/66 % in the ACSSF group (35/50; 30/45); (p = 0.005/p = 0.021). At 1-year/3-year FU, in the area of point C (≤ -1 cm), we achieved a 94 %/91 % effectiveness in the MESH group (49/52; 42/46) vs 90 %/80 % in the ACSSF group (45/50; 36/45); (p = 0.005/p = 0.192). In the MESH group, we observed a more frequent occurrence of "de novo" SUI (11 % vs 6 %) and a defect in the unoperated (posterior) compartment (18 % vs 8 %); the difference was not statistically signifi cant. CONCLUSION: Our study showed that the vaginal synthetic mesh repair of POP did not improve women's outcomes in terms of effectiveness or adverse effects, while the patient satisfaction is the same as compared to that with sacrospinous ligament fi xation at a 3-year FU. In gynecology, there are situations in which the comparison replaces the scientifi c solution (Tab. 5, Fig. 2, Ref. 50).

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 89%

Single‑incision mesh vs sacrospinous ligament fixation in posthysterectomy women at a three-year follow-up: a randomized trial

Galad¹,

Papcun²,

Dudič³

et al. 2020

BLL

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“…The system for anterior and apical prolapse repair consists of mesh anatomically designed to cover the anterior area. They include fixing arms to allow accurate mesh placement and intraoperative tensioning, and apical and anterior needles to allow fixation of the mesh to the sacrospinous ligament and obturator internus muscle, respectively [8,9]. The apical portion of the mesh is adjustable to vaginal length prior to fixing [10].…”

Section: Methodsmentioning

confidence: 99%

Outcomes of Single Incision Anchored Anterior Vaginal Mesh Repair for Recurrent Vaginal Prolapse

Loganathan

2020

COGO

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Objective: To report the safety and efficacy of single incision anchored anterior vaginal mesh repair for women with recurrent anterior vaginal prolapse.Methods: Retrospective study of women with recurrent anterior vaginal prolapse, Stage 2 or beyond, who underwent single incision anchored vaginal mesh repair with Anterior Elevate (American Medical Systems, Minnetonka, USA) between June 2012 and October 2016. Pre-operatively, the Prolapse Quality-of-Life questionnaire (P-QOL) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12) were completed. Post-operatively, women completed the P-QOL, PISQ-12 and the global impression of improvement questionnaire (PGI-I). Preoperative POP-Q and post operative POP-Q examination at up to 24 months follow up were recorded. At average follow up of 36 months, participants were interviewed via telephone using questions from the P-QOL, PISQ and PGI-I.Results: 45 women had single incision anterior vaginal mesh kit repair for recurrent prolapse. Postoperatively, 85% of women reported cure of their prolapse symptoms. At 24 months, 80.0% had POP-Q stage 0 or 1 in the anterior compartment, and 93.8% achieved anatomical cure of apical prolapse (point C above 0). During structured telephone interview at mean follow up of 36 months, on PGI-I, 70% reported feeling ‘much better’ or ‘very much better’.Conclusion: Vaginal surgery using single incision lightweight mesh kits can be an effective approach for women with recurrent anterior vaginal prolapse, resulting in subjective and objective cure rates of over 80% with reasonable safety profile up to 60 months postoperatively.

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“…Данная система представляет собой полипропиленовый сетчатый имплантат с 4 рукавами для бестроакарной фиксации (так называемая single-incision system), передняя пара фиксируется к обтураторному комплексу, задняяк крестцово-остистым связкам. Эффективность применения эндопротеза Elevate Apical & Anterior при 12 месяцах контроля, по данным некоторых исследований, достигает 98 %, при двухлетнем контроле находится в пределах 89,0-90,0 % [19][20][21]. Описанные в данных работах анатомические результаты сопоставимы с полученным в нашем исследовании: 94,8 % в течение 1 года и 92,7 % к 2 годам контроля.…”

Section: дискуссияunclassified

Vaginal apical and anterior reconstruction using ultralight weight mesh: two-year follow-up

et al. 2018

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Introduction. Anterior and apical prolapse is the most common type of pelvic organ prolapse. The insufficient effectiveness of native tissue repair in the pelvic organs leads to the search of new methods of the pelvic floor reconstruction. Objective. The current analysis was undertaken to evaluate the efficiency of the use of the Pelvix anterior mesh system (Lintex) with sacrospinous fixation of the apex in the treatment of anterior and apical prolapse. Methods. This study involved 150 women suffering from anterior-apical prolapse (stages III and IV). Reconstruction with the use of the mesh was performed in all the patients. To evaluate the results of surgical treatment, data of a vaginal examination (POP-Q), uroflowmetry, bladder ultrasound, and validated questionnaires (PFDI-20, PFIQ-7, PISQ-12) were used. All the listed parameters were determined before the surgery and on follow-up visits in 1, 6, 12, and 24 months after the treatment. Results. Mean operation time was 47 minutes. No cases of intraoperative clinically significant bleeding were reported. Anatomical cure rate (< stage II / asymptomatic stage II, according to the Baden-Walker system) at 12 months was found to be 94.4%, and at 24 months — 92.7%. Within the first month of follow-up, de novo stress urinary incontinence and de novo urgency occurred in 8.0% and 7.2% of patients, respectively. Statistically significant (p < 0.05) improvement in uroflowmetry parameters and decreased post-voiding urine volume were achieved after the surgery and did not change by 24 months. Comparison of the scores by the questionnaires revealed a significant improvement in the quality of life in the postoperative period. Conclusion. The use of the Pelvix anterior mesh system in the surgical correction of the anterior and apical prolapse is a safe uterus-sparing technique. At two-year follow-up, it provides a high anatomical efficiency, normalizes urodynamic parameters and improves quality of life.

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

Cited by 6 publications

References 26 publications

Single‑incision mesh vs sacrospinous ligament fixation in posthysterectomy women at a three-year follow-up: a randomized trial

Single‑incision mesh vs sacrospinous ligament fixation in posthysterectomy women at a three-year follow-up: a randomized trial

Outcomes of Single Incision Anchored Anterior Vaginal Mesh Repair for Recurrent Vaginal Prolapse

Vaginal apical and anterior reconstruction using ultralight weight mesh: two-year follow-up

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