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Partially absorbable mesh or native tissue repair for pelvic organ prolapse: a randomized controlled trial.

Abstract：

INTRODUCTION AND HYPOTHESIS:The objective was to compare medium-term efficacy and safety of a partially absorbable mesh kit and native tissue repair in pelvic organ prolapse (POP). MATERIALS AND METHODS:Women with primary POP stage ≥ II were randomized to transvaginal trocar-guided partially absorbable mesh (81 women) or native tissue repair (82 women). Primary outcome was overall anatomical success (POP < stage II) at 24 months. Secondary outcomes were composite success, global improvement, and adverse events. RESULTS:Sixty-nine (85%) of the women allocated to partially absorbable mesh underwent mesh surgery; 8 (10%) crossed over to native tissue repair and 4 women (5%) withdrew from the study. Eighty (98%) of the women allocated to native tissue repair underwent the assigned treatment and 2 (2%) withdrew. Twenty-four months later, 140 surgically treated women (89%) demonstrated an overall anatomical success of 39%; 45% (32 out of 71 women) for mesh, and 32% (22 out of 69) for native tissue repair (RR 1.4, 95% CI 0.92 to 2.2). Composite success was 88 and 73% respectively (RR: 1.1, 95% CI 0.93 to 1.4). There was global improvement in 86% (48 out of 56 women) in the mesh group and in 77% (47 out of 60 women) in the native tissue group (RR: 1.1, 95% CI 0.92 to 1.3). Four women were diagnosed with mesh exposure at 2 years (6%). CONCLUSION:At 24 months, no significant anatomical or composite benefit of partially absorbable mesh over native tissue repair could be demonstrated in women who had been surgically treated for primary POP.

journal_name

Int Urogynecol J

journal_title

International urogynecology journal

authors

Steures P,Milani AL,van Rumpt-van de Geest DA,Kluivers KB,Withagen MIJ

doi

10.1007/s00192-018-3757-5

subject

Has Abstract

pub_date

2019-04-01 00:00:00

pages

565-573

issue

4

eissn

0937-3462

issn

1433-3023

pii

10.1007/s00192-018-3757-5

journal_volume

30

pub_type

杂志文章,多中心研究,随机对照试验

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