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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

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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.

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References

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

  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. 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.

    PubMed  Google Scholar 

  10. Cobb WS, Kercher KW, Heniford BT. The argument for lightweight polypropylene mesh in hernia repair. Surg Innov. 2005;12(1):63–9.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

  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.

    Article  PubMed  Google Scholar 

  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. 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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  34. Aponte MM, Rosenblum N. Repair of pelvic organ prolapse: what is the goal? Curr Urol Rep. 2014;15(2):385.

    Article  PubMed  Google Scholar 

  35. Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009;114(3):600–9.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  37. Ou R, Xie XJ, Zimmern PE. Prolapse follow-up at 5 years or more: myth or reality? Urology. 2011;78(2):295–9.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

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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).

Author information

Author notes

  1. Lucie Allègre and Geertje Callewaert contributed equally to this work

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France

    Lucie Allègre, Geertje Callewaert & Renaud de Tayrac

  2. Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium

    Geertje Callewaert

  3. Department of Obstetrics and Gynecology, Nîmes University Hospital, Place du Pr Debré, 30029, Nîmes Cedex 9, France

    Geertje Callewaert

  4. Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, University of Montpellier, Nîmes, France

    Sandrine Alonso

  5. Department of Obstetrics and Gynecology, Clinique Beau Soleil, Montpellier, France

    Arnaud Cornille

  6. Department of Obstetrics and Gynecology, Kremin Bicêtre Hospital, Kremin Bicêtre, France

    Hervé Fernandez

  7. Department of Obstetrics and Gynecology, Clinique Champeau, Béziers, France

    Georges Eglin

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  1. Lucie Allègre
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Corresponding author

Correspondence to Geertje Callewaert.

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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.

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Allègre, L., Callewaert, G., Alonso, S. et al. 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. Int Urogynecol J 31, 745–753 (2020). https://doi.org/10.1007/s00192-019-04073-x

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