Advertisement

Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse

  • Lucie Allègre
  • Geertje CallewaertEmail author
  • Sandrine Alonso
  • Arnaud Cornille
  • Hervé Fernandez
  • Georges Eglin
  • Renaud de Tayrac
Original Article
  • 29 Downloads

Abstract

Introduction and hypothesis

The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair.

Methods

Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5–8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires.

Results

Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%).

Conclusion

Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.

Keywords

Long-term outcome Pelvic organ prolapse Cystocele Vaginal surgery Polypropylene mesh Anterior colporrhaphy 

Notes

Acknowledgements

We would like to show our gratitude to our colleagues from the other participating centers: Dr. Nizar Aflak, Dr. Jérôme Blanchot, Dr. Pierre-Louis Broux, Dr. Olivier Guilbaud, Dr. Aslam Monsoor, Prof. Xavier Deffieux, Prof. Loïc Marpeau, Dr. Vincent Descheemaeker, Dr. Philippe Ferry, and Dr. Sandrine Campagne. We also wish to thank the members of the BESPIM for the data management and statistical analysis (especially Dr. Pascale Fabbro-Peray, methodologist and Stéphanie Salles, data manager), and Dr. Sarah Kabani (for English editing), Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), Nîmes University Hospital, Nîmes, France.

Funding

This research was supported by the Nîmes University Hospital (Local Project 2013).

Compliance with ethical standards

Conflicts of interest

R. de Tayrac is consultant for Boston Scientific, has had research funding from Sofradim-Covidien, Boston Scientific, and has accepted speaker’s fees from Boston Scientific, Coloplast, and American Medical Systems. G. Eglin has acted as a consultant for Sofradim. H. Fernandez is a consultant for American Medical Systems. L. Allègre, G. Callewaert, A. Cornille, O. Guilbaud, A. Mansoor, and S. Alonso have no conflicts of interest to declare.

References

  1. 1.
    Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(6):1201–6.CrossRefGoogle Scholar
  2. 2.
    Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010;116(5):1096–100.CrossRefGoogle Scholar
  3. 3.
    Shah AD, Kohli N, Rajan SS, Hoyte L. The age distribution, rates, and types of surgery for pelvic organ prolapse in the USA. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(3):421–8.CrossRefGoogle Scholar
  4. 4.
    Vollebregt A, Fischer K, Gietelink D, van der Vaart CH. Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh. BJOG. 2011;118(12):1518–27.CrossRefGoogle Scholar
  5. 5.
    Diez-Itza I, Aizpitarte I, Becerro A. Risk factors for the recurrence of pelvic organ prolapse after vaginal surgery: a review at 5 years after surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(11):1317–24.CrossRefGoogle Scholar
  6. 6.
    Abed H, Rahn DD, Lowenstein L, et al. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J. 2011;22(7):789–98.CrossRefGoogle Scholar
  7. 7.
    Health, C.f.D.a.R., Public Health Notifications (Medical Devices)—FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. 2011.Google Scholar
  8. 8.
    SCENIHR. Opinion on the safety of surgical meshes used in urogynecological surgery. 2015. https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_049.pdf
  9. 9.
    Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11:Cd004014.Google Scholar
  10. 10.
    Cobb WS, Kercher KW, Heniford BT. The argument for lightweight polypropylene mesh in hernia repair. Surg Innov. 2005;12(1):63–9.CrossRefGoogle Scholar
  11. 11.
    Klosterhalfen B, Junge K, Klinge U. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices. 2005;2(1):103–17.CrossRefGoogle Scholar
  12. 12.
    Zinther NB, Wara P, Friis-Andersen H. Shrinkage of intraperitoneal onlay mesh in sheep: coated polyester mesh versus covered polypropylene mesh. Hernia. 2010;14(6):611–5.CrossRefGoogle Scholar
  13. 13.
    de Tayrac R, Alves A, Therin M. Collagen-coated vs noncoated low-weight polypropylene meshes in a sheep model for vaginal surgery. A pilot study. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(5):513–20.CrossRefGoogle Scholar
  14. 14.
    De Tayrac R, Cornille A, Eglin G, Guilbaud O, Mansoor A, Alonso S, Fernandez H. Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT. Int Urogynecol J. 2013;24(10):1651–61.Google Scholar
  15. 15.
    Barber MD, Neubauer NL, Klein-Olarte V. Can we screen for pelvic organ prolapse without a physical examination in epidemiologic studies? Am J Obstet Gynecol. 2006;195(4):942–8.CrossRefGoogle Scholar
  16. 16.
    De Tayrac R, Chauveaud-Lambling A, Fernandez D, Fernandez H. Quality of life instruments for women with pelvic organ prolapse. J Gynecol Obstet Biol Reprod (Paris). 2003;32(6):503–7.Google Scholar
  17. 17.
    Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003;14(3):164–8, discussion 168.CrossRefGoogle Scholar
  18. 18.
    Bump RC, Mattiasson A, Bø K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996;175(1):10–7.CrossRefGoogle Scholar
  19. 19.
    Haylen BT, Freeman RM, Swift SE, et al. An International Urogynecological Association (IUGA) / International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2011;22(1):3–15.CrossRefGoogle Scholar
  20. 20.
    Srikrishna S, Robinson D, Cardozo L. Validation of the patient global impression of improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010;21(5):523–8.CrossRefGoogle Scholar
  21. 21.
    Geller EJ, Barbee ER, Wu JM, Loomis MJ, Visco AG. Validation of telephone administration of 2 condition-specific quality-of-life questionnaires. Am J Obstet Gynecol. 2007;197(6):632.e1–4.CrossRefGoogle Scholar
  22. 22.
    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(10067):381–92.CrossRefGoogle Scholar
  23. 23.
    Milani AL, Damoiseaux A, IntHout J, Kluivers KB, Withagen MIJ. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial. Int Urogynecol J. 2018;29(6):847–58.CrossRefGoogle Scholar
  24. 24.
    Heinonen P, Aaltonen R, Joronen K, Ala-Nissilä S. Long-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int Urogynecol J. 2016;27(7):1069–74.CrossRefGoogle Scholar
  25. 25.
    Pecheux 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;232:33–9.CrossRefGoogle Scholar
  26. 26.
    Withagen MI, Vierhout ME, Hendriks JC, Kluivers KB, Milani AL. Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet Gynecol. 2011;118(3):629–36.CrossRefGoogle Scholar
  27. 27.
    Chughtai B, Barber MD, Mao J, Forde JC, Normand ST, Sedrakyan A. Association between the amount of vaginal mesh used with mesh erosions and repeated surgery after repairing pelvic organ prolapse and stress urinary incontinence. JAMA Surg. 2017;152(3):257–63.CrossRefGoogle Scholar
  28. 28.
    Liang R, Abramowitch S, Knight K, et al. Vaginal degeneration following implantation of synthetic mesh with increased stiffness. BJOG. 2013;120(2):233–43.CrossRefGoogle Scholar
  29. 29.
    Frankman EA, Alperin M, Sutkin G, Meyn L, Zyczynski HM. Mesh exposure and associated risk factors in women undergoing transvaginal prolapse repair with mesh. Obstet Gynecol Int. 2013;2013:926313.CrossRefGoogle Scholar
  30. 30.
    Eilber KS, Alperin M, Khan A, et al. The role of the surgeon on outcomes of vaginal prolapse surgery with mesh. Female Pelvic Med Reconstr Surg. 2017;23(5):293–6.CrossRefGoogle Scholar
  31. 31.
    Collinet P, Belot F, Debodinance P, Ha Duc E, Lucot JP, Cosson M. Transvaginal mesh technique for pelvic organ prolapse repair: mesh exposure management and risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(4):315–20.CrossRefGoogle Scholar
  32. 32.
    Lee DM, Nazroo J, O’Connor DB, Blake M, Pendleton N. Sexual health and well-being among older men and women in England: findings from the English longitudinal study of ageing. Arch Sex Behav. 2016;45(1):133–44.CrossRefGoogle Scholar
  33. 33.
    Bell S, Reissing ED, Henry LA, VanZuylen H. Sexual activity after 60: a systematic review of associated factors. Sex Med Rev. 2017;5(1):52–80.CrossRefGoogle Scholar
  34. 34.
    Aponte MM, Rosenblum N. Repair of pelvic organ prolapse: what is the goal? Curr Urol Rep. 2014;15(2):385.CrossRefGoogle Scholar
  35. 35.
    Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009;114(3):600–9.CrossRefGoogle Scholar
  36. 36.
    Weber AM, Abrams P, Brubaker L, et al. The standardization of terminology for researchers in female pelvic floor disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(3):178–86.CrossRefGoogle Scholar
  37. 37.
    Ou R, Xie XJ, Zimmern PE. Prolapse follow-up at 5 years or more: myth or reality? Urology. 2011;78(2):295–9.CrossRefGoogle Scholar
  38. 38.
    Eilber KS, Alperin M, Khan A, et al. Outcomes of vaginal prolapse surgery among female Medicare beneficiaries: the role of apical support. Obstet Gynecol. 2013;122(5):981–7.CrossRefGoogle Scholar
  39. 39.
    Abrams P, Andersson KE, Apostolidis A, et al. 6th International Consultation on Incontinence. Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence. Neurourol Urodyn. 2018;37(7):2271–2.CrossRefGoogle Scholar

Copyright information

© The International Urogynecological Association 2019

Authors and Affiliations

  1. 1.Department of Obstetrics and Gynecology, CHU NîmesUniversity of MontpellierNîmesFrance
  2. 2.Department of Obstetrics and GynecologyUniversity Hospitals LeuvenLeuvenBelgium
  3. 3.Department of Obstetrics and GynecologyNîmes University HospitalNîmes Cedex 9France
  4. 4.Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU NîmesUniversity of MontpellierNîmesFrance
  5. 5.Department of Obstetrics and GynecologyClinique Beau SoleilMontpellierFrance
  6. 6.Department of Obstetrics and GynecologyKremin Bicêtre HospitalKremin BicêtreFrance
  7. 7.Department of Obstetrics and GynecologyClinique ChampeauBéziersFrance

Personalised recommendations