Prolene mesh comparing with sacrospinal fixation in the treatment of genital prolapse in women. Prospective multicentre randomized study

Czech version

Authors: M. Halaška ¹; O. Šottner ¹; K. Maxová ¹; L. Krofta ²; K. Švabík ³; T. Rittstein ⁴; M. Mlčoch ⁵; M. Krčmář ²; M. J. Halaška ⁶ ; Z. Adamík ⁵; I. Malá ⁷; A. Martan ³ ; J. Feyereisl ²
Authors‘ workplace: Gynekologicko-porodnická klinika 1. LF UK a FN Na Bulovce, Praha, přednosta prof. MUDr. M. Halaška, DrSc. ¹; Ústav pro péči o matku a dítě, Praha, ředitel doc. MUDr. J. Feyereisl, CSc. ²; Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha, přednosta prof. MUDr. A. Martan, DrSc. ³; Gynekologické oddělení Ústřední vojenské nemocnice, Praha, přednostka prim. MUDr. H. Kašpárková ⁴; Gynekologicko-porodnické oddělení Baťovy nemocnice, Zlín, přednosta prim. MUDr. Z. Adamík, PhD. ⁵; Gynekologicko-porodnická klinika 2. LF UK a FN Motol, Praha, přednosta prof. MUDr. L. Rob, CSc. ⁶; Fakulta informatiky a statistiky VŠE, Praha, vedoucí doc. RNDr. L. Marek, CSc. ⁷
Published in: Ceska Gynekol 2010; 75(2): 126-132

Overview

Objective:
Polypropylene mesh in the treatment of genital prolapse in women was introduced at the turn of the millennium with the rationale of decreasing surgical invasiveness, reinforcing weak tissues and to possibly complement insufficient surgical techniques. Prospective randomized studies comparing traditional and modern operations are lacking.

Subject:
Prospective multicentre randomized study.

Setting:
Department of Obstetrics and Gynaecology, The First Faculty of Medicine, Charles University in Prague.

Subject and method:
A prospective multicentre trial was approved by the Ministry of Health of the Czech Republic and registered with the FDA planning to recruit 500 patients with vaginal prolapse, 18 years of age and over, undergoing surgery at 5 major urogynaecologic centres. The patients were divided into three groups according to prolapse predominance. The surgical techniques used were: anterior and posterior prolift, and randomly allocated total prolift or sacrospinous fixation. The examination setup included lower urinary tract ultrasound, MRI, POP-Q assessment and QoL questionnaires before surgery and six and 24 month after the surgery.

Conclusion:
Preliminary analysis of partial data of 225 women showed an acceptable rate of complications and a better success rate in the mesh groups, whereas operation time and blood loss was lower in the classical operation group. Quality of life questionnaires documented that all the methods used have comparably good results. The surgical techniques used are acceptable methods for pelvic organ prolapse repair with low complication rates and excellent impact on the subjective perception of the patient’s quality of life.

Key words:
prolapse, mesh, sacrospinous fixation, Prolift, Amreich, stress urinary incontinence.

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