Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse

Abstract

IMPORTANCE Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. OBJECTIVE To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. DESIGN, SETTING, PARTICIPANTS At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. INTERVENTIONS Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. MAIN OUTCOMES AND MEASURES The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. RESULTS A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, −45.2 [95% CI, −57.7 to −32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). CONCLUSIONS AND RELEVANCE Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.

Outcomes of vaginal hysterectomy combined with anterior and posterior colporrhaphy for pelvic organ prolapse: a single center retrospective study

“…[n=81] vs. 156.7±43.9 min [n=87]) [15,23]. The blood transfusion rate and the difference in Hb levels in our study were comparable with those in a previous study (transfusion, 0.98% [6/610]; difference in Hb, 1.7±1.0 g/dL vs. transfusion, 1.9% [2/108]; difference in Hb, 2.0 g/dL) [24].…”

Prospective analysis of transvaginal mesh hysteropexy in the treatment of uterine prolapse

“…This is similar to the Scandinavian study where the total mesh group had better apical support [26]. The SUPEr trial [27], a randomized clinical trial of hysteropexy with vaginal mesh augmentation versus a hysterectomy and vaginal vault support, showed that at 36 months the model-estimated failure was 26% for the hysteropexy group and 38% for the hysterectomy group.…”

“…Our mean EBL in this study was 179 (± 116) ml. This is slightly higher but still comparable to blood loss reported in the SUPEr trial [27], which randomized 183 women to transvaginal mesh hysteropexy vs. hysterectomy/ ULS (141.1 ± 104.0 ml vs. 147.5 ± 97.4 ml, respectively, p = 0.68). We acknowledge the potential for significant bleeding in this procedure as bilateral paravaginal and pararectal dissection is required; however, with careful technique and attention to hemostasis, hemorrhagic morbidity can be mitigated.…”

“…The reason we feel the information from this study, albeit short term, is germane is because of the April 2019 FDA advisory mandating the withdrawal of transvaginal mesh [13]. Our findings and those of others [27,33] show a successful uterine-sparing role of transvaginal mesh hysteropexy especially for advanced stage (III/IV) prolapse and makes a strong case for re-instituting this procedure for this unique indication to be performed under strict research settings. Not all patients with prolapse require mesh augmentation.…”

Vaginal Colposuspension Using the Uphold Lite Mesh System versus Transvaginal Hysterectomy with Uterosacral Ligament Suspension for Treatment of Apical Prolapse: A Comparative Study

“…The composite outcome, including prolapse symptoms, prolapse beyond the hymen, or need of reoperation, did not differ between the groups. The authors also reported on the shorter duration of surgery in the vaginal mesh group as well as an 8% erosion rate [19]. Rahkola-Soisalo et al [20] presented a cohort of 164 women treated for POP using the Uphold Lite system.…”