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International Urogynecology Journal

Published in:

01-05-2018 | Original Article

Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse—2-year follow-up

Authors: Gil Levy, Anna Padoa, Zoltan Fekete, George Bartfai, Laszlo Pajor, Mauro Cervigni

Published in: International Urogynecology Journal | Issue 5/2018

Abstract

Introduction and hypothesis

The search for an improved vaginal mesh prompted the development of a new anchorless implant. The objective was to report on outcome after 2 years of a technique using a self-retaining support (SRS) implant.

Methods

Patients with anterior vaginal wall prolapse, with/without apical prolapse, were recruited. Participants underwent surgical repair using the SRS device. Demographic data, pre-surgical Pelvic Organ Prolapse Quantification (POP-Q) scoring, quality of life (QoL) questionnaires (Pelvic Floor Distress Inventory Short Form 20 [PFDI-20], Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 [PISQ-12]), and surgical data were collected. Patients were followed at 2 weeks, 2, 6, 12, and 24 months after surgery. Objective anatomical success was defined using the NIH criteria.

Results

Twenty women were recruited for the study with an average age of 62.1 years and an average parity of 4.0 deliveries. Average BMI was 28. Pre-operative mean POP-Q measurements were Aa =1.40 (−1 to 3) cm, Ba = 2.3 (−1 to 6) cm and C = 0.4 (−7 to 6) cm. Surgical time averaged 31.2 min. Estimated blood loss averaged 165 ml. No intra-operative complications were observed. One case (5%) of frame erosion was documented 8 months after surgery. At 2 years’ follow-up, mean POP-Q measurements were: Aa = −2.95 (−3 to −2) cm, Ba = −2.85 (−3 to −2) cm, and C point −6.90 (−10 to −3) cm. Seventeen (85%) patients had stage 0 and 3 patients (15%) had stage 1. No mesh erosions or chronic pelvic pain were documented at follow-up. The total PFDI score at follow-up was decreased by 92.8 points (p < 0.0001).

Conclusions

At 2 years’ follow-up, the SRS implant was found to be safe, showing no intra-operative or immediate post-operative complications. All women presented with POP-Q measurements of the anterior and apical compartment at normal value (Ba ≤ −2 cm) and statistically significant subjective improvement.

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Title: Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse—2-year follow-up
Authors: Gil Levy
Anna Padoa
Zoltan Fekete
George Bartfai
Laszlo Pajor
Mauro Cervigni
Publication date: 01-05-2018
Publisher: Springer London
Published in: International Urogynecology Journal / Issue 5/2018
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-017-3415-3

At a glance: The STEP trials

Springer Medicine

Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse—2-year follow-up

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

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