nach oben

Erschienen in:

19.01.2022 | Original Article

Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial

verfasst von: Renaud de Tayrac, Michel Cosson, Laure Panel, Clara Compan, Mohammed Zakarya Zemmache, Sophie Bouvet, Laurent Wagner, Brigitte Fatton, Géry Lamblin

Erschienen in: International Urogynecology Journal | Ausgabe 7/2022

Einloggen, um Zugang zu erhalten

Abstract

Introduction and hypothesis

The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.

Methods

A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4–8 weeks and 11–13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.

Results

Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22–4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia “usually or always” were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).

Conclusions

Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.

Fritel X, Varnoux N, Zins M, et al. Symptomatic pelvic organ prolapse at midlife, quality of life, and risk factors. Obstet Gynecol. 2009;113:609–16. https://doi.org/10.1097/AOG.0b013e3181985312.CrossRefPubMedPubMedCentral

Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501–6. https://doi.org/10.1016/S0029-7844(97)00058-6.CrossRefPubMed

Lucot JP, Cosson M, Bader G, et al. Safety of vaginal mesh surgery versus laparoscopic mesh sacropexy for cystocele repair: results of the prosthetic pelvic floor repair randomized controlled trial. Eur Urol. 2018;74:167–76. https://doi.org/10.1016/j.eururo.2018.01.044.CrossRefPubMed

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;2(2):CD012079.PubMed

Vu MK, Letko J, Jirschele K, et al. Minimal mesh repair for apical and anterior prolapse: initial anatomical and subjective outcomes. Int Urogynecol J Pelvic Floor Dysfunct. 2012;23:1753–61. https://doi.org/10.1007/s00192-012-1780-5.CrossRef

Letouzey V, Ulrich D, Balenbois E, et al. Utero-vaginal suspension using bilateral vaginal anterior sacrospinous fixation with mesh: intermediate results of a cohort study. Int Urogynecol J. 2015;26:1803–7. https://doi.org/10.1007/s00192-015-2748-z.CrossRefPubMed

Altman D, Mikkola TS, Bek KM, et al. Pelvic organ prolapse repair using the Uphold™ vaginal support system: a 1-year multicenter study. Int Urogynecol J. 2016;27:1337–45. https://doi.org/10.1007/s00192-016-2973-0.CrossRefPubMed

Lucot JP, Cosson M, Verdun S, et al. Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial. BJOG. 2022;129(1):127–37. https://doi.org/10.1111/1471-0528.16847.CrossRefPubMed

Baessler K, Christmann-Schmid C, Maher C, et al. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence. Cochrane Database Syst Rev. 2018;8(8):CD013108.PubMed

10.

Fatton B, de Tayrac R, Letouzey V, Huberlant S. Pelvic organ prolapse and sexual function. Nat Rev Urol. 2020;17:373–90.CrossRef

11.

Fatton B, Hermieu J-F, Lucot J-P, et al. French validation of the pelvic organ prolapse/incontinence sexual questionnaire-IUGA revised (PISQ-IR). Int Urogynecol J. 2021;32(12):3183–98. https://doi.org/10.1007/s00192-020-04625-6.CrossRefPubMed

12.

Leruth J, Fillet M, Waltregny D. Incidence and risk factors of postoperative stress urinary incontinence following laparoscopic sacrocolpopexy in patients with negative preoperative prolapse reduction stress testing. Int Urogynecol J Pelvic Floor Dysfunct. 2013;24:485–91. https://doi.org/10.1007/s00192-012-1888-7.CrossRef

13.

Wagner L, Boileau L, Delmas V, et al. Surgical treatment of prolapse using coelioscopic promontofixation: techniques and results. Prog Urol. 2009;19:994–1005.CrossRef

14.

LeClaire EL, Mukati MS, Juarez D, et al. Is de novo stress incontinence after sacrocolpopexy related to anatomical changes and surgical approach? Int Urogynecol J. 2014;25:1201–6. https://doi.org/10.1007/s00192-014-2366-1.CrossRefPubMed

15.

Salerno J, de Tayrac R, Droupy S, et al. Impact de la promonto-fixation cœlioscopique, avec ou sans bandelette sous-urétrale, sur les symptômes du bas appareil urinaire. Prog Urol. 2016;26:401–8. https://doi.org/10.1016/j.purol.2016.03.003.CrossRefPubMed

16.

Bousserghine Y, Droupy S, Wagner L, et al. Incontinence urinaire d’effort de novo après promontofixation. Prog Urol. 2011;21:631–5. https://doi.org/10.1016/j.purol.2011.04.004.CrossRefPubMed

17.

El Hamamsy D, Fayyad AM. New onset stress urinary incontinence following laparoscopic sacrocolpopexy and its relation to anatomical outcomes. Int Urogynecol J. 2015;26:1041–5. https://doi.org/10.1007/s00192-015-2641-9.CrossRefPubMed

18.

Holt E. US FDA rules manufacturers to stop selling mesh devices. Lancet. 2019;393:1686. https://doi.org/10.1016/S0140-6736(19)30938-9.CrossRefPubMed

19.

Department of Error. Lancet. 2019;393:2124. https://doi.org/10.1016/S0140-6736(19)31093-1

20.

Maher CF, Feiner B, Decuyper EM, et al. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011;204:360.e1–7. https://doi.org/10.1016/j.ajog.2010.11.016.CrossRef

21.

Bataller E, Ros C, Anglès S, et al. Anatomical outcomes 1 year after pelvic organ prolapse surgery in patients with and without a uterus at a high risk of recurrence: a randomised controlled trial comparing laparoscopic sacrocolpopexy/cervicopexy and anterior vaginal mesh. Int Urogynecol J. 2019;30:545–55. https://doi.org/10.1007/s00192-018-3702-7.CrossRefPubMed

22.

Gutman RE, Rardin CR, Sokol ER, et al. Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study. Am J Obstet Gynecol. 2017;216:38.e1–11.CrossRef

23.

To V, Hengrasmee P, Lam A, et al. Evidence to justify retention of transvaginal mesh: comparison between laparoscopic sacral colpopexy and transvaginal Elevate™ mesh. Int Urogynecol J. 2017;28:1825–32. https://doi.org/10.1007/s00192-017-3379-3.CrossRefPubMed

24.

Wei D, Wang P, Niu X, Zhao X. Comparison between laparoscopic uterus/sacrocolpopexy and total pelvic floor reconstruction with vaginal mesh for the treatment of pelvic organ prolapse. J Obstet Gynaecol Res. 2019;45:915–22. https://doi.org/10.1111/jog.13908.CrossRefPubMedPubMedCentral

25.

Ehlert MJ, Gupta P, Park J, Sirls LT. Detailed cost analysis of robotic sacrocolpopexy compared to transvaginal mesh repair. Urology. 2016;97:86–91. https://doi.org/10.1016/j.urology.2016.05.072.CrossRefPubMed

26.

Myoga M, Sho T, Aoki H, et al. Cost analysis of four types of surgeries for pelvic organ prolapse in a Japanese population. J Obstet Gynaecol Res. 2021;47:1567–71. https://doi.org/10.1111/jog.14683.CrossRefPubMed

Titel: Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial
verfasst von: Renaud de Tayrac
Michel Cosson
Laure Panel
Clara Compan
Mohammed Zakarya Zemmache
Sophie Bouvet
Laurent Wagner
Brigitte Fatton
Géry Lamblin
Publikationsdatum: 19.01.2022
Verlag: Springer International Publishing
Erschienen in: International Urogynecology Journal / Ausgabe 7/2022
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-021-05071-8

Update Gynäkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert – ganz bequem per eMail.

Newsletter bestellen

Springer Medizin

Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial