One year follow-up of the Ingynious mesh
IUGA Academy. Ulrich D. Jun 30, 2018; 212890; 378 Topic: Pelvic Organ Prolapse
Assoc. Prof. Daniela Ulrich
Assoc. Prof. Daniela Ulrich

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378

One year follow-up of the Ingynious mesh

Ulrich, D1; Kuszka, A2; Kociszewski, J2; Niesel, A3; Fünfgeld, C4; Kieback, D5; Kropshofer, S6; Brandt, A7

1: Medical University Graz, Austria; 2: Lutheran Hospital Hagen, Germany; 3: Klinik Preetz, Germany; 4: Klinik Tettnang GmbH, Germany; 5: Helios Klinikum Schleswig, Germany; 6: Medical University Innsbruck, Austria; 7: ORTENAU KLINIKUM Offenburg-Gengenbach, Germany

Introduction: Pelvic organ prolapse (POP) is a major burden for the public health system affecting up to 20% of all women during their life (Walker and Gunasekera, 2011). There is heated debate about vaginal mesh surgery with companies withdrawing their kits from the market and whole countries banning vaginal meshes. Quite recently an ultra lightweight mesh kit has been introduced into POP surgery that can be fixated with 6 arms.

Objective: The aim of this study was to describe the safety and anatomical results of a surgical approach with a single-incision 6 point fixation vaginal mesh for the treatment of pelvic organ prolapse at one year follow-up.

Methods: This is a prospective observational study of patients who underwent operation with a transvaginal mesh (InGYNious ®, AMI Austria) between November 2014 and June 2016 in 6 urogynaecological centres. Ethical approval was granted by the local ethics committees. All patients presenting with stage II prolapse or higher (point Ba or C >-1 according to the international prolapse quantification system) were included in the study. A structured questionnaire and a clinical examination were performed preoperatively and after 12 months. Anatomical success was defined as < 0 (POPQ) for both anterior and apical compartments.

Results: 247 patients operated with the InGYNious system were available for the 12 months follow up. Intraoperative complications occurred rarely; 15 (6%) patients had haemorrhage of more than 200ml, 2 patients had intraoperative bladder lesions with none of them having issues at one year follow-up. Anatomical success at the latest follow up visit was 95%; for both the anterior and apical compartments. Mesh erosion rate was low with 1.6% (n=4). Reoperations were performed for postoperative hematoma (2%), prolapse recurrence in any compartment (3%), mesh revision (0.6%), and a ureteral stent (0.3%). 36% of the study population had preoperative incontinence; reoperation for postoperative SUI was only performed in 10% of all cases out of 237 patients without primary concomitant incontinence surgery. Quality of life increased significantly after one year.

Discussion: This is the first study to report on the follow up of the InGYNious mesh and its anatomical and functional outcome. The objective cure rate was high with a concomitant high patient satisfaction rate. Mesh related problems were rare suggesting that this surgical technique can be an option for women requiring prolapse surgery.

References

WALKER, G. J. A. & GUNASEKERA, P. 2011. Pelvic organ prolapse and incontinence in developing countries: review of prevalence and risk factors. International Urogynecology Journal, 22, 127-135.

Disclosure:

Work supported by industry: yes, by AMI. A consultant, employee (part time or full time) or shareholder is among the authors (AMI).

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