Abstract
Introduction and hypothesis
This study assessed the safety and efficacy of vaginal extraperitoneal uterosacral ligament suspension (VEULS) with anterior overlay mesh versus sacrocolpopexy (SCP) for posthysterectomy vault prolapse.
Methods
This was a multicenter randomized trial of women with posthysterectomy vault prolapse stage >2 according to the Pelvic Organ Prolapse Quantification (POP-Q) system. Primary outcome was a composite of no vaginal bulge symptoms, no anatomical recurrence in the anterior or apical compartment at or beyond the hymenal ring, and no surgical retreatment for prolapse 12 months postsurgery. Secondary outcomes were peri- and postoperative complications, changes in prolapse, and urogenital and sexual symptoms at 12, 24, and 48 months based on the Pelvic Floor Distress Inventory (PFDI)-20.
Results
Between 2006 and 2011, 82 eligible women were randomized: 39 received VEULS and 43 received SCP. Primary composite outcome at 12 months for success was 41% for VEULS and 65% for SCP [odds ratio (OR 2.68, p = 0.03)]. Perioperative complications were more common in the SCP group. C-point was higher for SCP (−6.0 VEULS vs −8.0 SCP, p = 0.005) and total vaginal length (TVL) was longer for SCP (8.0 VEULS vs 9.0 SCP, p = 0.05). Cumulative mesh exposure rate at 4 years was similar between the uterosacral [4/39 (10.3%)] and sacrocolpopexy [4/43 (9.3%)] groups, bearing in mind that not all patients were examined at 4 years. Subjective outcomes derived from three domains of the PFDI-20 were similar at 12, 24, 48 months. Postoperative Pelvic Organ Prolapse Distress Inventory (POPDI) score improved similarly for both groups at all timepoints, with the minimally important difference of at least 21 reached for both groups.
Conclusions
Composite outcome of success was better for SCP at 12 months, but subjective outcomes for prolapse at all timepoints over 4 years for VEULS and SCP were not significantly different.
Similar content being viewed by others
References
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.
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.
Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010;116(5):1096–100.
Marchionni M, Bracco GL, Checcucci V, Carabaneanu A, Coccia EM, Mecacci F, et al. True incidence of vaginal vault prolapse thirteen years of experience. J Reprod Med. 1999;44(8):679–84.
Aigmueller T, Dungl A, Hinterholzer S, Geiss I, Riss P. An estimation of the frequency of surgery for posthysterectomy vault prolapse. Int Urogynecol J. 2010;21(3):299–302.
Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Datab Systemat Rev. 2016(10).
Silva WA, Pauls RN, Segal JL, Rooney CM, Kleeman SD, Karram MM. Uterosacral ligament vault suspension: five-year outcomes. Obstet Gynecol. 2006;108(2):255–63.
Fatton B, Dwyer PL, Achtari C, Tan PK. Bilateral extraperitoneal uterosacral vaginal vault suspension: a 2-year follow-up longitudinal case series of 123 patients. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(4):427–34.
Rondini C, Braun H, Alvarez J, Urzúa MJ, Villegas R, Wenzel C, et al. High uterosacral vault suspension vs Sacrocolpopexy for treating apical defects: a randomized controlled trial with twelve months follow-up. Int Urogynecol J. 2015;26(8):1131–8.
Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011;204(4):360.e1–7.
Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter PJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol. 2004;190(1):20–6.
Chan SS, Cheung RY, Lai BP, Lee LL, Choy KW, Chung TK. Responsiveness of the pelvic floor distress inventory and pelvic floor impact questionnaire in women undergoing treatment for pelvic floor disorders. Int Urogynecol J. 2013;24(2):213–21.
Tincello DG, Alfirevic Z. Important clinical outcomes in urogynecology: views of patients, nurses and medical staff. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2):96–8. discussion 8
Barber MD, Walters MD, Cundiff GW, Group PT. Responsiveness of the pelvic floor distress inventory (PFDI) and pelvic floor impact questionnaire (PFIQ) in women undergoing vaginal surgery and pessary treatment for pelvic organ prolapse. Am J Obstet Gynecol. 2006;194(5):1492–8.
Barber MD, Spino C, Janz NK, Brubaker L, Nygaard I, Nager CW, et al. The minimum important differences for the urinary scales of the pelvic floor distress inventory and pelvic floor impact questionnaire. Am J Obstet Gynecol. 2009;200(5):580.e1–7.
Jelovsek JE, Chen Z, Markland AD, Brubaker L, Dyer KY, Meikle S, et al. Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence. Female Pelvic Med Reconstr Surg. 2014;20(6):342–8.
Vallabh-Patel V, Saiz C, Salamon C. Subjective and objective outcomes of robotic and vaginal high uterosacral ligament suspension. Female Pelvic Med Reconstr Surg. 2016;22(6):420–4.
Sanses TV, Shahryarinejad A, Molden S, Hoskey KA, Abbasy S, Patterson D, et al. Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: a Fellows' pelvic research network study. Am J Obstet Gynecol. 2009;201(5):519.e1–8.
Jambusaria LH, Murphy M, Lucente VR. One-year functional and anatomic outcomes of robotic sacrocolpopexy versus vaginal extraperitoneal colpopexy with mesh. Female Pelvic Med Reconstr Surg. 2015;21(2):87–92.
Chung CP, Miskimins R, Kuehl TJ, Yandell PM, Shull BL. Permanent suture used in uterosacral ligament suspension offers better anatomical support than delayed absorbable suture. Int Urogynecol J. 2012;23(2):223–7.
Siddiqui NY, Grimes CL, Casiano ER, Abed HT, Jeppson PC, Olivera CK, et al. Mesh sacrocolpopexy compared with native tissue vaginal repair: a systematic review and meta-analysis. Obstet Gynecol. 2015;125(1):44–55.
Mowat A, Maher C, Pelecanos A. Can the Learning Curve of Laparoscopic Sacrocolpopexy Be Reduced by a Structured Training Program? Female Pelvic Med Reconstr Surg. 2017.
Unger CA, Walters MD, Ridgeway B, Jelovsek JE, Barber MD, Paraiso MF. Incidence of adverse events after uterosacral colpopexy for uterovaginal and pysterectomy vault prolapse. Am J Obstet Gynecol. 2015;212(5):603.e1–7.
Acknowledgements
We thank Prof. Leonid Churliov for providing statistical support.
Funding
There was no external funding or technical assistance with the production of this article.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interests
LO, CM, ET, AL have no financial interests, commercial affiliations, or other possible conflicts of interest.
PD, YL, JL, and AR have received a departmental grant from Boston Scientific and AMS for investigator-led studies of Uphold and midurethral slings, but this study has not received funding. AR was an advisory board member for Astellas in 2017.
Details of ethics approval
Approval for this randomized trial was provided by Mercy Health Human Research & Ethics Committee (R07/12 and R16/05) and Monash Medical Centre.
Rights and permissions
About this article
Cite this article
Ow, L.L., Lim, Y.N., Lee, J. et al. RCT of vaginal extraperitoneal uterosacral ligament suspension (VEULS) with anterior mesh versus sacrocolpopexy: 4-year outcome. Int Urogynecol J 29, 1607–1614 (2018). https://doi.org/10.1007/s00192-018-3687-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00192-018-3687-2