CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd 2017; 77(09): 993-1001
DOI: 10.1055/s-0043-116857
GebFra Science
Original Article/Originalarbeit
Georg Thieme Verlag KG Stuttgart · New York

Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months

Article in several languages: English | deutsch
Christian Fünfgeld
1   Klinik Tettnang GmbH, Tettnang, Germany
,
Margit Stehle
1   Klinik Tettnang GmbH, Tettnang, Germany
,
Brigit Henne
2   St. Elisabeth Krankenhaus, Leipzig, Germany
,
Jan Kaufhold
3   Regionale Kliniken Holding RKH GmbH, Ludwigsburg, Germany
,
Dirk Watermann
4   Evangelisches Diakoniekrankenhaus, Freiburg, Germany
,
Markus Grebe
5   Städtisches Klinikum Dresden-Friedrichstadt, Dresden, Germany
,
Mathias Mengel
6   Klinikum Oberlausitzer Bergland gemeinnützige GmbH, Zittau, Germany
› Author Affiliations
Further Information

Publication History

received 02 April 2017
revised 12 July 2017

accepted 16 July 2017

Publication Date:
25 September 2017 (online)

Abstract

Introduction Pelvic organ prolapse can significantly reduce quality of life of affected women, with many cases requiring corrective surgery. The rate of recurrence is relatively high after conventional prolapse surgery. In recent years, alloplastic meshes have increasingly been implanted to stabilize the pelvic floor, which has led to considerable improvement of anatomical results. But the potential for mesh-induced risks has led to a controversial discussion on the use of surgical meshes in urogynecology. The impact of cystocele correction and implantation of an alloplastic mesh on patientsʼ quality of life/sexuality and the long-term stability of this approach were investigated.

Method In a large prospective multicenter study, 289 patients with symptomatic cystocele underwent surgery with implantation of a titanized polypropylene mesh (TiLOOP® Total 6, pfm medical ag) and followed up for 36 months. Both primary procedures and procedures for recurrence were included in the study. Anatomical outcomes were quantified using the POP-Q system. Quality of life including sexuality were assessed using the German version of the validated P-QoL questionnaire. All adverse events were assessed by an independent clinical event committee.

Results Mean patient age was 67 ± 8 years. Quality of life improved significantly over the course of the study in all investigated areas, including sexuality and personal relationships (p < 0.001, Wilcoxon test). The number of adverse events which occurred in the period between 12 and 36 months after surgery was low, with just 22 events reported. The recurrence rate for the anterior compartment was 4.5%. Previous or concomitant hysterectomy increased the risk of recurrence in the posterior compartment 2.8-fold and increased the risk of erosion 2.25-fold.

Conclusion Cystocele correction using a 2nd generation alloplastic mesh achieved good anatomical and functional results in cases requiring stabilization of the pelvic floor and in patients with recurrence. The rate of recurrence was low, the patientsʼ quality of life improved significantly, and the risks were acceptable.

 
  • References/Literatur

  • 1 Deutsche Gesellschaft für Gynäkologie und Geburtshilfe (DGGG), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Diagnostik und Therapie des weiblichen Descensus genitalis. 2016 Online: http://www.awmf.org/uploads/tx_szleitlinien/015-006l_S2e_Descensus_genitalis-Diagnostik-Therapie_2016-11.pdf last access: 15.08.2017
  • 2 Slieker-ten Hove MC, Pool-Goudzwaard AL, Eijkemans MJ. et al. The prevalence of pelvic organ prolapse symptoms and signs and their relation with bladder and bowel disorders in a general female population. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20: 1037-1045
  • 3 Mengel M, Henne B, Fünfgeld C. et al. Entwicklung des Miktionsverhaltens unter Belastungsbedingungen und Lebensqualität nach netzgestützter Zystozelenkorrektur. Gynäkologische Praxis 2015; 39: 10
  • 4 Weber AM, Walters MD, Piedmonte MR. Sexual function and vaginal anatomy in women before and after surgery for pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol 2000; 182: 1610-1615
  • 5 Fünfgeld C, Mengel M, Henne B. et al. Zystozelenkorrektur mit alloplastischen Netzen. Frauenarzt 2015; 56: 1068-1073
  • 6 Farthmann J, Fuenfgeld C, Mengel M. et al. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet 2016; 294: 115-121
  • 7 Abdel-Fattah M, Akinbowale F, Schinee B. et al. Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study. BMJ Open 2011; 1: e000206
  • 8 Slieker-ten Hove MC, Pool-Goudzwaard AL, Eijkemans MJC. et al. Symptomatic pelvic organ prolapse and possible risk factors in a general population. Am J Obstet Gynecol 2009; 200: 184.e1-184.e7
  • 9 Olsen AL, Smith VJ, Clark AL. et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997; 89: 501-506
  • 10 Julian TM. The efficacy of Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal wall. Am J Obstet Gynecol 1996; 175: 1472-1475
  • 11 Shull BL, Benn SJ, Kuehl TJ. Surgical management of prolapse of the anterior vaginal segment: an analysis of support defects, operative morbidity, and anatomic outcome. Am J Obstet Gynecol 1994; 171: 1429-1436 discussion 1436–1439
  • 12 Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2011; (12) CD003882
  • 13 Denman MA, Gregory WT, Boyles SH. Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol 2008; 198: 555e1-555e5
  • 14 Maher C, Feiner B, Baessler K. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev 2016; (02) CD012079
  • 15 Barski DT, Otto T, Gerullis H. Systematic review and classification of complications after anterior, posterior, apical, and total vaginal mesh implantation for prolapse repair. Surg Technol Int 2014; 24: 217-224
  • 16 UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA Safety Communication. 2011 Online: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm last access: 15.08.2017
  • 17 Bump RC, Mattiasson A, Bo K. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996; 175: 10-17
  • 18 Digesu GA, Khullar V, Cardozo L. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2005; 16: 176-181
  • 19 Lenz F, Stammer H, Brocker K. et al. Validation of a German version of the P-QOL Questionnaire. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20: 641-649
  • 20 Schar G, Kolbl H, Voigt R. [Recommendations by the Urogynecology Working Group for sonography of the lower urinary tract within the scope of urogynecologic functional diagnosis]. Ultraschall Med 1996; 17: 38-41
  • 21 National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) 4.03. N.C. Institute, ed. Washington, D.C.: U.S. Department of Health and Human Services/National Institutes of Health; 2010
  • 22 Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010; 152: 726-732
  • 23 Statistisches Bundesamt. Results of Microcensus 2013. 2013 Online: https://www.destatis.de/EN/FactsFigures/SocietyState/Health/HealthStatusBehaviourRelevantHealth/Tables/BodyMassIndex.html Last access: 19.06.2017
  • 24 Institut für das Entgeltsystem im Krankenhaus. G-DRG V2013 Browser 2012 § 21 KHEntgG. 2013 Online: http://www.g-drg.de/content/view/full/4887 last access: 19.06.2017
  • 25 Chapple CR, Cruz F, Deffieux X. Consensus statement of the European Urology Association and the European Urogynaecological Association on the use of implanted materials for treating pelvic organ prolapse and stress urinary incontinence. Eur Urol 2017; DOI: 10.1016/j.eururo.2017.03.048.
  • 26 Glazener CM, Breeman S, Elders A. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet 2017; 389: 381-392
  • 27 El Haddad R, Svabik K, Masata J. Womenʼs quality of life and sexual function after transvaginal anterior repair with mesh insertion. Eur J Obstet Gynecol Reprod Biol 2013; 167: 110-113
  • 28 Yesil A, Watermann D, Farthmann J. Mesh implantation for pelvic organ prolapse improves quality of life. Arch Gynecol Obstet 2014; 289: 817-821 doi:10.1007/s00404-013-3052-0
  • 29 Thomin A, Touboul C, Hequet D. Genital prolapse repair with Avaulta Plus mesh: functional results and quality of life. Prog Urol 2013; 23: 270-275
  • 30 Hefni M, Barry JA, Koukoura O. Long-term quality of life and patient satisfaction following anterior vaginal mesh repair for cystocele. Arch Gynecol Obstet 2013; 287: 441-446
  • 31 Maher C, Feiner B, Baessler K. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013; (04) CD004014
  • 32 Zyczynski HM, Rickey L, Dyer KY. Sexual activity and function in women more than 2 years after midurethral sling placement. Am J Obstet Gynecol 2012; 207: 421e1-421e6
  • 33 Rogers RG, Kammerer-Doak D, Darrow A. et al. Does sexual function change after surgery for stress urinary incontinence and/or pelvic organ prolapse? A multicenter prospective study. Am J Obstet Gynecol 2006; 195: e1-e4
  • 34 Yang TH, Wu LY, Chuang FC. Comparing the midterm outcome of single incision vaginal mesh and transobturator vaginal mesh in treating severe pelvic organ prolapse. Taiwan J Obstet Gynecol 2017; 56: 81-86
  • 35 El-Khawand D, Wehbe SA, OʼHare PG. Risk factors for vaginal mesh exposure after mesh-augmented anterior repair: a retrospective cohort study. Female Pelvic Med Reconstr Surg 2014; 20: 305-309
  • 36 Gold KP, Ward RM, Zimmerman CW. Factors associated with exposure of transvaginally placed polypropylene mesh for pelvic organ prolapse. Int Urogynecol J 2012; 23: 1461-1466
  • 37 Farthmann J, Watermann D, Niesel A. Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial. Int Urogynecol J 2013; 24: 749-758
  • 38 Iyer S, Botros SM. Transvaginal mesh: a historical review and update of the current state of affairs in the United States. Int Urogynecol J 2017; 28: 527-535
  • 39 Caliskan E, Özdamar Ö. Should uterus be removed at pelvic organ prolapse surgery: a reappraisal of the current propensity. Pelviperineology 2017; 36: 24-32
  • 40 Ridgeway B, Chen CC, Paraiso MF. The use of synthetic mesh in pelvic reconstructive surgery. Clin Obstet Gynecol 2008; 51: 136-152
  • 41 Scientific Committee on Emerging and Newly-Identified Health Risks SCENIHR. Opinion on the safety of surgical meshes used in urogynecological surgery 2015. Online: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_049.pdf last access: 19.06.2017