Short Periods of Observation
The evaluation of Dannecker’s interdisciplinary group of authors, of surgical procedures for urinary incontinence in women, differs from the guideline of the Association of the Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF) (1). The key message, that tension-free slings should be preferred and that colposuspension should be used only for recurrences, needs to be qualified. Observational periods of 2 years or less are not sufficient for a reliable evaluation (2). For alloplastic materials, the AWMF is asking for more randomized studies with longer follow-up and sufficient statistical power. Consequently, the AWMF rates open colposuspension as the type of continence surgery with the highest efficacy in long term follow-up for primary surgery as well as after recurrences (evidence level Ia).
Further, the increased occurrence of severe complications after implantation of alloplastic material deserves particular attention (3). Before alloplastic materials become routinely used in clinical practice, animal experiments as well as consecutive clinical studies are required for the material as well as the indication. Unfortunately, the legal requirements in the past were too lax, which means that more than 200 (!) different types of meshes are available for use in hernia operations, prolapse surgery, and continence surgery.
Dr. med. Jens W. Bagner
Prof. Dr. med. Bernd Klosterhalfen
Prof. Dr. med. Thomas Otto
Städtische Kliniken Neuss, Lukaskrankenhaus GmbH
Preussenstr. 84, 41464 Neuss, Germany
Deutsches Zentrum zur Entwicklung und Prüfung innovativer Techniken
in der Medizin e.V.
Conflict of interest statement
The authors declare that no conflict of interest exists according to the guidelinesof the International Committee of Medical Journal Editors.
|1.||Leitlinien der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe (DGGG), DGGGG AUBid: Belastungsinkontinenz der Frau AWMF -Leitlinien-Register Nr.15/005 2008.|
|2.||Ward KL, Hilton P: A prospective multicenter randomized trial of tension free vaginal tape and colposuspension for primary urinary stress incontinence: two-year follow-up. Am J Obstet Gynecol 2004; 190(2): 324–31. MEDLINE|
|3.||Otto T: Warnung vor der Verwendung alloplastischen Materials. Deutsches Ärzteblatt 2009; 106(34–35): A1654. VOLLTEXT|
|4.||Dannecker Ch, Friese K, Stief Ch, Bauer R: Urinary incontinence in women—part 1 of a series of articles on incontinence. Dtsch Arztebl Int 2010; 107(24): 420–6. VOLLTEXT|