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Erschienen in: International Urogynecology Journal 4/2020

10.09.2019 | Original Article

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

verfasst von: Lucie Allègre, Geertje Callewaert, Sandrine Alonso, Arnaud Cornille, Hervé Fernandez, Georges Eglin, Renaud de Tayrac

Erschienen in: International Urogynecology Journal | Ausgabe 4/2020

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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.
Literatur
1.
Zurück zum Zitat 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.PubMedPubMedCentralCrossRef 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.PubMedPubMedCentralCrossRef
2.
Zurück zum Zitat Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010;116(5):1096–100.CrossRefPubMed Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010;116(5):1096–100.CrossRefPubMed
3.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
4.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
5.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
6.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
7.
Zurück zum Zitat 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. 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.
9.
Zurück zum Zitat 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 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
10.
Zurück zum Zitat Cobb WS, Kercher KW, Heniford BT. The argument for lightweight polypropylene mesh in hernia repair. Surg Innov. 2005;12(1):63–9.PubMedCrossRef Cobb WS, Kercher KW, Heniford BT. The argument for lightweight polypropylene mesh in hernia repair. Surg Innov. 2005;12(1):63–9.PubMedCrossRef
11.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
12.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
13.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
14.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
16.
Zurück zum Zitat 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. 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.
17.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
18.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
19.
Zurück zum Zitat 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.CrossRef 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.CrossRef
20.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
21.
Zurück zum Zitat 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.CrossRef 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.CrossRef
22.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
23.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
24.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
25.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
26.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
27.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
28.
Zurück zum Zitat Liang R, Abramowitch S, Knight K, et al. Vaginal degeneration following implantation of synthetic mesh with increased stiffness. BJOG. 2013;120(2):233–43.PubMedPubMedCentralCrossRef Liang R, Abramowitch S, Knight K, et al. Vaginal degeneration following implantation of synthetic mesh with increased stiffness. BJOG. 2013;120(2):233–43.PubMedPubMedCentralCrossRef
29.
Zurück zum Zitat 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.PubMedPubMedCentralCrossRef 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.PubMedPubMedCentralCrossRef
30.
Zurück zum Zitat 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.PubMedPubMedCentralCrossRef 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.PubMedPubMedCentralCrossRef
31.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
32.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
33.
Zurück zum Zitat 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.CrossRef 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.CrossRef
34.
Zurück zum Zitat Aponte MM, Rosenblum N. Repair of pelvic organ prolapse: what is the goal? Curr Urol Rep. 2014;15(2):385.PubMedCrossRef Aponte MM, Rosenblum N. Repair of pelvic organ prolapse: what is the goal? Curr Urol Rep. 2014;15(2):385.PubMedCrossRef
35.
36.
Zurück zum Zitat 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.PubMedPubMedCentralCrossRef 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.PubMedPubMedCentralCrossRef
37.
Zurück zum Zitat Ou R, Xie XJ, Zimmern PE. Prolapse follow-up at 5 years or more: myth or reality? Urology. 2011;78(2):295–9.PubMedCrossRef Ou R, Xie XJ, Zimmern PE. Prolapse follow-up at 5 years or more: myth or reality? Urology. 2011;78(2):295–9.PubMedCrossRef
38.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
39.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
Metadaten
Titel
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
verfasst von
Lucie Allègre
Geertje Callewaert
Sandrine Alonso
Arnaud Cornille
Hervé Fernandez
Georges Eglin
Renaud de Tayrac
Publikationsdatum
10.09.2019
Verlag
Springer International Publishing
Erschienen in
International Urogynecology Journal / Ausgabe 4/2020
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-019-04073-x

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