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RCT of vaginal extraperitoneal uterosacral ligament suspension (VEULS) with anterior mesh versus sacrocolpopexy: 4-year outcome

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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.

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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.

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Correspondence to Lin Li Ow.

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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.

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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

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  • DOI: https://doi.org/10.1007/s00192-018-3687-2

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