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Registry of implants for the reconstruction of pelvic floor in males and females: a feasibility case series: Beyond the Abstract

The future of surgical care depends on the research we do now. If we don`t address the current shortfalls catastrophic problems like falsified research outcome and bad quality implants and surgical techniques will destroy patients faith and make good techniques disappear. 

Especially in pelvic floor surgery we use high risk medical products with sensitive structures. Good skills and standard procedures based on high level of evidence are needed. Women have an 11% lifetime risk of needing surgery for pelvic floor disorders and 1 of 3 patients requiring additional surgery for prolapse or incontinence [1]. More than 200 thousand surgical procedures for pelvic organ prolapse were undertaken in 1997 in the United States, at an estimated cost of more than $1 billion [2,3]. However there is a lack of homogenity and long-term data for the materials and techniques utilized. Additionally, no generally accepted definition for success after pelvic prolapse surgery exists. Outcome based on anatomic success only has a weak or absent correlation with patient perception of outcome [4]. Multiple questionnaires and definitions complicate the comparability of the studies. From 2008 on, the FDA released several reports on more than 1000 unexpected and severe adverse events, associated with trans-vaginal placement of surgical mesh. It took 8 more years that FDA finally required premarket approval and postmarket surveillance studies for trans-vaginal meshes [5]. FDA started to collaborate with the international expert group IDEAL in order to establish new requirements following the IDEAL-recommendations [6].

Herewith we present a development of registry for a standardized benchmarking of pelvic floor surgery. Different modules for female prolapse, female incontinence and male incontinence have been developed.

There are four main outcomes, which have been considered for the definition of success [7,8]:

  1. Patient satisfaction and impact on health-related quality of life;
  2. Anatomical reposition;
  3. Continence;
  4. Avoidance of complications.
Based on the successful implementation of surgical hernia registries, f.e. European registry for abdominal wall hernias (EuraHs), a working group under auspices of the German Society of Residents in Urology (GeSRU) and the Study Group for Urogynecology and Plastic Pelvic Floor Reconstruction (AGUB) of the German Society for Gynecology and Obstetrics was built. Our approach conforms to the IDEAL-system of surgical innovation. We propose a gradual process of registry establishment to overcome the inconsistent voluntary participation and reporting. First, an implementation of quality depending reimbursement is needed by the politics. A successful registry based on the experience and consent of participating gynecological and urological societies will pave the way for the mandatory registry system driven by politics and with the financial support of the participating industrial manufacturers. Registries will provide timely, more accurate, and reliable research results with sufficient information to uniquely identify the device. Data access and analytical processes should be transparent, to enable quality improvement and the best possible and individualized care for the patients. Following the hernia registries, an established national registry will pave the way for the European registry of pelvic floor implants.

Written By: Dimitri Barski, MD, Department of Urology, Lukas Hospital Neuss, Germany; Thomas Otto, MD, Department of Urology, Lukas Hospital, Neuss, Germany

1. Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89(4):501–506. doi: 10.1016/S0029-7844(97)00058-6.
2. Brown JS, Waetjen LE, Subak LL, et al. Pelvic organ prolapse surgery in the United States, 1997. Am J Obstet Gynecol. 2002;186:712–716. doi: 10.1067/mob.2002.121897. 
3. Subak LL, Waetjen LE, Eeden S, et al. Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol. 2001;98:646–651. doi: 10.1016/S0029-7844(01)01472-7.
4. Barber MD, Brubaker L, Nygaard I, et al. Pelvic floor disorders network: Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009;114(3):600–9. doi: 10.1097/AOG.0b013e3181b2b1ae.
5. FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Accessed 25 Apr 2017.
6. McCulloch P, Altman DG, Campbell WB, et al. No surgical 357 innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105-12. doi:10.1016/S0140-6736(09)61116-8.
7. Lee U, Raz S. Emerging concepts for pelvic organ prolapse surgery: What is cure? Curr Urol Rep. 2011 Feb;12(1):62-7. doi: 10.1007/s11934-010-0160-2.
8. Mearini L, Zucchi A, Nunzi E, Di Biase M, Bini V, Costantini E. The S.A.C.S. (Satisfaction-Anatomy-Continence-Safety) score for evaluating pelvic organ prolapse surgery: a proposal for an outcome-based scoring system. Int Urogynecol J. 2015;26(7):1061-1067.376 doi:10.1007/s00192-015-2655-3.

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