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CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd 2024; 84(03): 256-263
DOI: 10.1055/a-2243-2341
GebFra Science
Original Article

Surgical Procedures for the Treatment of Stress Urinary Incontinence (SUI) in the Light of the Updated FDA-Warning and its Effects on Practice Patterns in Germany between 2010 and 2021

Operative Eingriffe zur Behandlung der Belastungsharninkontinenz nach der Aktualisierung der FDA-Warnung und deren Auswirkung auf die Praxis in Deutschland zwischen 2010 und 2021
Gert Naumann
1   Department of Gynecology and Obstetrics, Helios Hospital Erfurt, Erfurt, Germany (Ringgold ID: RIN62480)
2   Department of Obstetrics and Gynecology, University of Düsseldorf, Düsseldorf, Germany
,
Markus Huebner 
3   Department of Obstetrics and Gynecology, Medical Center – University of Freiburg, Freiburg, Germany (Ringgold ID: RIN14879)
4   Faculty of Medicine, University of Freiburg, Freiburg, Germany (Ringgold ID: RIN9174)
5   Faculty of Medicine, University of Tübingen, Tübingen, Germany
,
Florin-Andrei Taran
3   Department of Obstetrics and Gynecology, Medical Center – University of Freiburg, Freiburg, Germany (Ringgold ID: RIN14879)
,
Ralf Tunn
6   Department of Urogynecology, German Pelvic Floor Center, St. Hedwig Hospital, Berlin, Germany (Ringgold ID: RIN371656)
,
Christl Reisenauer
5   Faculty of Medicine, University of Tübingen, Tübingen, Germany
7   Department of Womenʼs Health, University Hospital of Tübingen, Tübingen, Germany
,
Felix Neis 
5   Faculty of Medicine, University of Tübingen, Tübingen, Germany
7   Department of Womenʼs Health, University Hospital of Tübingen, Tübingen, Germany
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Abstract

Introduction

Changes in surgical practice patterns to cure stress urinary incontinence (SUI) became evident after FDA warnings regarding vaginal mesh were issued. The primary aim was to describe nationwide numbers of suburethral alloplastic slings (SAS) inserted in 2010, 2015, 2018 and 2021 in Germany. Secondary, numbers were related to SUI specific non-alloplastic alternatives and bulking agents. Additionally, age distribution and overall inpatient surgeries in women were subject to analysis.

Materials and Methods

Descriptive study utilizing data gathered from the German Federal Statistical Office (www.destatis.de). Included were the following procedures of inpatient surgery: A. SAS; B. non-allplastic slings; C. open/laparoscopic colposuspension; D. Bulking agents; overall changes and changes in age distribution (groups of 5-years intervals) are described.

Results

Overall, n = 3599466 female inpatient procedures were analyzed. There was a considerable decrease of SAS surgeries of 28.49% between 2010 (n = 23464) and 2015 (n = 16778), and a decrease of 12.42% between 2015 and 2018 (n = 14695) and an additional decrease of 40.66% between 2018 and 2021 (n = 8720). Over time a 55.03% continuous decrease in non-alloplastic slings was observed (n = 725 in 2010 to n = 326 in 2021). Open and laparoscopic colposuspension numbers went down with a rate of 58.23% (n = 4415 in 2010, n = 1844 in 2021). Between 2010 and 2018, only bulking agent procedures increased with a rate of 5.89% from n = 1425 to n = 1509.

Conclusions

There was a considerable decrease in inpatient surgical procedures using SAS. Alternatives not only failed to compensate, but experienced also a major decline.

Zusammenfassung

Einleitung

Nachdem die FDA Warnungen zu Vaginalnetzen herausgegeben hat, hat sich die chirurgische Praxis zur Behandlung der Belastungsharninkontinenz deutlich geändert. Das Hauptziel dieser Arbeit war, die Anzahl bundesweit durchgeführter Eingriffe mit suburethralen alloplastischen Schlingen (SAS) in den Jahren 2010, 2015, 2018 und 2021 in Deutschland zu beschreiben. Sekundär wurde die Anzahl belastungsharninkontinenzspezifischer, nicht-alloplastischer Alternativen und der Einsatz von Bulking Agents geprüft. Die Altersverteilung der Patientinnen und die Gesamtheit der stationären operativen Eingriffe bei Frauen wurden ebenfalls analysiert.

Material und Methoden

Es handelt sich um eine deskriptive Studie, die sich auf Daten des Statistischen Bundesamts in Deutschland (www.destatis.de) stützt. Eingeschlossen wurden folgende stationäre operative Eingriffe: A. SAS; B. nicht alloplastische Schlingen; C. die offene/laparoskopische Kolposuspension; D. Bulking Agents; allgemeine Veränderungen und Änderungen in der Altersverteilung (Gruppen wurden in 5-Jahres-Intervalle eingeteilt) werden beschrieben.

Ergebnisse

Insgesamt wurden 3599466 stationäre Eingriffe bei Frauen analysiert. Es gab einen erheblichen Rückgang an SAS-Eingriffen (28,49%) zwischen 2010 (n = 23464) und 2015 (n = 16778); zwischen 2015 und 2018 (n = 14695) betrug der Rückgang 12,42% und zwischen 2018 und 2021 (n = 8720) sank der Prozentsatz zusätzlich um 40,66%. Im Laufe der Zeit wurde ein kontinuierlicher Rückgang von 55,03% bei Einsatz nicht alloplastischer Schlingen beobachtet (von n = 725 im Jahre 2010 zu n = 326 in 2021). Die Anzahl offener und laparoskopischer Kolposuspensionen ging ebenfall um 58,23% zurück (von n = 4415 im Jahre 2010 auf n = 1844 in 2021). Zwischen 2010 und 2018 stieg nur die Anzahl der Eingriffe mit Bulking Agents um 5,89% von n = 1425 auf n = 1509.

Schlussfolgerungen

Es kam zu einem erheblichen Rückgang der stationären operativen SAS-Eingriffe. Alternative Prozeduren schafften nicht nur keinen Ausgleich, sondern erlebten auch einen erheblichen Rückgang.

Keywords

stress urinary incontinence (SUI) - tension free vaginal tape (TVT) - FDA warning - colposuspension - bulking agents

Schlüsselwörter

Belastungsharninkontinenz - spannungsfreie vaginale Schlinge - FDA-Warnung - Kolposuspension - Bulking Agents


Publikationsverlauf

Eingereicht: 24. Oktober 2023

Angenommen nach Revision: 10. Januar 2024

Artikel online veröffentlicht:
06. März 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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