Significant Improvement in Quality of Life, Positive Effect on Sexuality, Lasting Reconstructive Result and Low Rate of Complications Following Cystocele Correction Using a Lightweight, Large-Pore, Titanised Polypropylene Mesh

Abstract

Introduction Patients who suffer from pelvic organ prolapse can experience severe limitations in their quality of life. To improve the quality of life of women affected and achieve a stable reconstruction, surgical therapy is often indispensable. In conventional prolapse surgery, the rate of recurrence is high. For this reason, alloplastic mesh has been implanted increasingly in recent years to reconstruct the anatomy of the pelvic floor organs. Even if the anatomical result can be significantly improved as a result, the mesh-induced complications have been the subject of controversial discussion. In this national, multicentre study, the quality of life, anatomical result as well as the rate of complications following the implantation of an alloplastic mesh for the correction of a cystocele were investigated.

Method Fifty-four patients with symptomatic ≥ grade II were included in this prospective, national, multicentre study. The study participants were implanted with a titanised polypropylene mesh (TiLOOP^® PRO A, pfm medical ag). The follow-up observation period was 12 months. Primary as well as repeat procedures were taken into account. The anatomic result of the pelvic floor reconstruction was quantified using the POP-Q system. Data on quality of life and sexuality were collected using validated questionnaires. All complications which occurred were documented and evaluated by an independent committee.

Results On average, the patients were in line with the census. An improvement in quality of life was able to be determined during the study in all domains investigated (p < 0.001, Wilcoxon test). Minus incorrect entries and incorrect reports, a total of 19 reports of adverse events in 15 patients were evaluated by the end of the study. The rate of recurrence in the anterior compartment was 4.3%.

Conclusion In the reconstruction of the anatomical position of the pelvic floor organs given the presence of a symptomatic cystocele, the implantation of a third-generation alloplastic mesh achieves very good results. Affected patients benefit from the anatomical stability as well as a significant improvement in quality of life, whereby the risks are justifiable.

Key words

alloplastic mesh - pelvic floor prolapse - quality of life - sexuality - POP-Q

• References/Literatur

• 1 Nygaard I, Barber MD, Burgio KL. et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA 2008; 300: 1311-1316
• 2 Ward RM, Velez Edwards DR, Edwards T. et al. Genetic epidemiology of pelvic organ prolapse: a systematic review. Am J Obstet Gynecol 2014; 211: 326-335
• 3 Deutsche Gesellschaft für Gynäkologie und Geburtshilfe (DGGG), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Diagnostik und Therapie des weiblichen Descensus genitalis. 2016. Online: https://www.awmf.org/uploads/tx_szleitlinien/015-006l_S2e_Descensus_genitalis-Diagnostik-Therapie_2016-11-verlaengert.pdf last access: 21.08.2019
• 4 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
• 5 Smith FJ, Holman CD, Moorin RE. et al. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 2010; 116: 1096-1100
• 6 Wu JM, Hundley AF, Fulton RG. et al. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol 2009; 114: 1278-1283
• 7 Dietz HP, Hankins KJ, Wong V. The natural history of cystocele recurrence. Int Urogynecol J 2014; 25: 1053-1057
• 8 Denman MA, Gregory WT, Boyles SH. et al. Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol 2008; 198: 555.e1-555.e5
• 9 Maher C, Feiner B, Baessler K. et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev 2016; (02) CD012079
• 10 Caquant F, Collinet P, Debodinance P. et al. Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients. J Obstet Gynaecol Res 2008; 34: 449-456
• 11 Funfgeld C, Stehle M, Henne B. et al. Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months. Geburtsh Frauenheilk 2017; 77: 993-1001
• 12 US Department of Health and Human Services; Food and Drug Administration, Center for Devices and Radiological Health. et al. UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. FDA Safety Communication. 2011. Online: http://2015.iuga.org/wp-content/uploads/workshops/ws29_literature7.pdf last access: 21.08.2019
• 13 FDA. FDA news release, FDA takes action to protect womenʼs health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. 16.04.2019. Online: https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical-mesh-intended-transvaginal last access: 21.08.2019
• 14 INEK [Institut für das Entgeltsystem im Krankenhaus]. Abfrage der Anzahl der Fälle mit OPS Codes zur Behandlung des Descensus genitalis im DRG Browser (§ 21 KHEntgG) von 1.1.2007- 31.12.2012: 5 – 704.01 Kolporrhaphia anterior mit alloplastischem Material, 5 – 704.11 Kolporrhaphia posterior mit alloplastischem Material und 5 – 704.4 g Scheidenstumpffixation vaginal, mit alloplastischem Material.
• 15 Guyomard A, Delorme E. Transvaginal treatment of anterior or central urogenital prolapse using six tension-free straps and light mesh. Int J Gynaecol Obstet 2016; 133: 365-369
• 16 Yesil A, Watermann D, Farthmann J. Mesh implantation for pelvic organ prolapse improves quality of life. Arch Gynecol Obstet 2013;
• 17 Farthmann J, Mengel M, Henne B. 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
• 18 Haylen BT, de Ridder D, Freeman RM. et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn 2010; 29: 4-20
• 19 Bump RC, Mattiasson A, Bo K. et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996; 175: 10-17
• 20 Persu C, Chapple CR, Cauni V. et al. Pelvic Organ Prolapse Quantification System (POP-Q) – a new era in pelvic prolapse staging. J Med Life 2011; 4: 75-81
• 21 Digesu GA, Khullar V, Cardozo L. et al. 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
• 22 Wedel T, Pauli F. Anatomische und chirurgische Grundlagen zur Netzrekonstruktion des Beckenbodens. Stuttgart: Thieme; 2010
• 23 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
• 24 Baessler K, Kempkensteffen C. [Validation of a comprehensive pelvic floor questionnaire for the hospital, private practice and research]. Gynakol Geburtshilfliche Rundsch 2009; 49: 299-307
• 25 National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) 4.03. Bethesda, Maryland, USA: National Cancer Institute; 2010
• 26 Statistisches Bundesamt. Results of Microcensus 2017. 18.03.2019 – 12211-0082 – Durchschnittliche Körpergröße, durchschnittliches Körpergewicht, durchschnittlicher Body-Mass-Index: Deutschland, Jahre, Geschlecht, Familienstand, Altersgruppen. Online: https://www.destatis.de last access: 04.04.2019
• 27 Institut für das Entgeltsystem im Krankenhaus. G-DRG V2013 Browser 2016 § 21 KHEntgG. 2017. Online: http://www.g-drg.de/content/view/full/4887 last access: 04.04.2019
• 28 Schulz KF, Altman DG, Moher D. et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010; 152: 726-732
• 29 Moore J, Armstrong JT, Willis SH. The use of tantalum mesh in cystocele with critical report of ten cases. Am J Obstet Gynecol 1955; 69: 1127-1135
• 30 Usher FC. Hernia repair with Marlex mesh. An analysis of 541 cases. Arch Surg 1962; 84: 325-328
• 31 Lane FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol 1962; 20: 72-77
• 32 Stanton SL, Cardozo LD. Results of the colposuspension operation for incontinence and prolapse. Br J Obstet Gynaecol 1979; 86: 693-697
• 33 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
• 34 Cosson M, Debodinance P, Boukerrou M. et al. Mechanical properties of synthetic implants used in the repair of prolapse and urinary incontinence in women: which is the ideal material?. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14: 169-178 discussion 178
• 35 Boukerrou M, Boulanger L, Rubod C. et al. Study of the biomechanical properties of synthetic mesh implanted in vivo. Eur J Obstet Gynecol Reprod Biol 2007; 134: 262-267
• 36 Fatton B, Amblard J, Debodinance P. et al. Transvaginal repair of genital prolapse: preliminary results of a new tension-free vaginal mesh (Prolift technique)–a case series multicentric study. Int Urogynecol J Pelvic Floor Dysfunct 2007; 18: 743-752
• 37 Milani AL, Hinoul P, Gauld JM. et al. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol 2011; 204: 74-78
• 38 Ghoniem G, Hammett J. Female pelvic medicine and reconstructive surgery practice patterns: IUGA member survey. Int Urogynecol J 2015; 26: 1489-1494
• 39 Pécheux O, Giraudet G, Drumez E. et al. Long-term (8.5 years) analysis of the type and rate of reoperation after transvaginal mesh repair (Prolift^®) in 349 patients. Eur J Obstet Gynecol Reprod Biol 2019; 232: 33-39
• 40 Palma PCR, Monteiro MVC, Ledesma MA. et al. Treatment of Anterior Vaginal Wall Prolapse Using Transvaginal Anterior Mesh With Apical Fixation: A Prospective Multicenter Study With up to 2 Years of Follow-up. Int Neurourol J 2018; 22: 177-184
• 41 Levy G, Padoa A, Fekete Z. et al. Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up. Int Urogynecol J 2017;
• 42 Chang YW, Chuang FC, Wu LY. et al. Evaluating the efficacy of the single-incision uphold system for pelvic organ prolapse repair. Taiwan J Obstet Gynecol 2019; 58: 94-98
• 43 Fünfgeld C, Cadenbach-Blome T, Mengel M. et al. Development of POP-related Symptoms, Quality of Life, Anatomical Results and Side Effects after Cystocele Correction with an Improved Titanized Mesh. International Society of Pelviperineology Congress. Bucharest: 2018
• 44 Rahkola-Soisalo P, Altman D, Falconer C. et al. Quality of life after Uphold Vaginal Support System surgery for apical pelvic organ prolapse-A prospective multicenter study. Eur J Obstet Gynecol Reprod Biol 2017; 208: 86-90
• 45 Hüsch T, Mager R, Ober E. et al. Quality of life in women of non-reproductive age with transvaginal mesh repair for pelvic organ prolapse: A cohort study. Int J Surg 2016; 33 Pt A: 36-41
• 46 Buca DIP, Liberati M, Falo E. et al. Long-term outcome after surgical repair of pelvic organ prolapse with Elevate Prolapse Repair System. J Obstet Gynaecol 2018; 38: 854-859
• 47 Glazener CM, Breeman S, Elders A. et al. 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
• 48 Mateu Arrom L, Errando Smet C, Gutierrez Ruiz C. et al. Pelvic Organ Prolapse Repair with Mesh: Mid-Term Efficacy and Complications. Urol Int 2018; 101: 201-205
• 49 Naumann G, Gabriel B, Baessler K. et al. Stellungnahme zur FDA Entscheidung des Verbotes von vaginalen Netzen im vorderen Scheidenbereich April 2019. Online: https://www.dggg.de/leitlinien-stellungnahmen/stellungnahmen/fda-entscheidung-des-verbotes-von-vaginalen-netzen-im-vorderen-scheidenbereich-1063/ last access: 21.08.2019
• 50 Vermeulen CKM, Coolen A, Spaans WA. et al. Treatment of vaginal vault prolapse in The Netherlands: a clinical practice survey. Int Urogynecol J 2018;
• 51 Fairclough E, Myers J, Smith ARB. et al. A UK questionnaire survey of current techniques used to perform pelvic organ prolapse repair. Int Urogynecol J 2017; 28: 1367-1376
• 52 Coolen AWM, Bui BN, Dietz V. et al. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J 2017; 28: 1767-1783