Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial

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.

Trial registration: ClinicalTrials.gov Identifier: NCT01802281.

Conflict of interest statement

Conflict of Interest Disclosures: All of the authors reported funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health and that Boston Scientific Corporation provided partial study support through an unrestricted grant to the data coordinating center. Dr Visco reported stock ownership in NinoMed. Dr Rardin reported grants from Pelvalon, Inc, Colace Therapeutics, and the Foundation for Female Health Awareness outside the submitted work. Dr Rogers reported receiving personal fees from the International Urogynecologic Association as the editor in chief for the International Urogynecology Journal, the American Board of Obstetrics and Gynecology as a member of the subspecialty board for the Female Pelvic Medicine and Reconstructive Surgery, and the American College of Obstetrics and Gynecology for teaching at the annual meeting, and royalties for writing for UpToDate on chapters describing the epidemiology of prolapse, its diagnosis and evaluation, as well as a chapter on the sexual function of women with pelvic floor disorders. Dr Paraiso reported receiving grants from Colopast and Caldera outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Participants in a Study of the Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy on Treatment Failure in Women With Uterovaginal Prolapse

Perforated colonic diverticulum was the cause of death for the participant lost to follow-up in the hysterectomy group at 0-12 months, lung cancer was the cause of death for the participant in the hysteropexy group during follow-up at 12-24 months, and leukemia was the cause of death for the participant in the hysterectomy group during follow-up at 12-24 months. POP-Q indicates Pelvic Organ Prolapse Quantification; PFDI, Pelvic Floor Distress Inventory.

Figure 2.. Failure Probability for the Composite Primary Outcome Comparing Hysteropexy With Hysterectomy in Women With Uterovaginal Prolapse

Failure probability from survival analysis excluding the 8 ineligible participants was conducted using an interval-censored proportional hazard model with an assumed baseline piecewise exponential hazard with 4 constant hazard periods: (0-12 months, 12-24 months, 24-36 months, and >36 months) and controlled for site consistent with study randomization as well as prior prolapse surgery per clinical standards. Available follow-up data were included for all participants through the time when the last participant reached 36 months of follow-up. At the time of analysis, 10 participants were censored prior to 36 months (7 in the hysteropexy group and 3 in the hysterectomy group), 50 participants were censored between 36 and 48 months (27 in the hysteropexy group and 23 in the hysterectomy group), and 50 were censored at or beyond 48 months (27 in the hysteropexy group and 23 in the hysterectomy group). The median (IQR) follow-up time was 36.0 (18.0-48.0) months for the hysteropexy group and 36.0 (9.0-48.0) for the hysterectomy group. The hazard rate in the hysteropexy group (incidence density per person-year) in year 1 was 0.16; year 2, 0.07; year 3, 0.06; and beyond 3 years, 0.05. In the hysterectomy group, the hazard rate in year 1 was 0.26; year 2, 0.12; year 3, 0.10; and beyond 3 years, 0.08. The failure probability from the sensitivity nonparametric interval-censored Kaplan-Meier analysis is represented by the dotted lines. The solid lines represent the piecewise exponential model and the 95% CI for the piecewise exponential model is shown by the blue shaded area for the hysterectomy group and the tan shaded area for the hysteropexy group.