Highlight
This landmark 10-year randomized clinical trial demonstrates that vaginal sacrospinous hysteropexy with mesh reduces composite failure risk compared to vaginal hysterectomy with uterosacral ligament suspension in treating uterovaginal prolapse. Both procedures maintain durable symptom relief and exhibit comparable safety profiles through extended follow-up.
Study Background
Uterovaginal prolapse is a prevalent pelvic floor disorder among postmenopausal women, causing discomfort, urinary and bowel dysfunction, and impaired quality of life. Vaginal hysterectomy combined with suture apical suspension has traditionally been the standard surgical approach for symptomatic uterovaginal prolapse. However, concerns about the impact of hysterectomy on pelvic support and patient preference for uterine preservation have spurred investigation into uterine-sparing alternatives such as vaginal sacrospinous hysteropexy with graft augmentation. Despite advances, there remains limited long-term comparative evidence to guide surgical decision-making, with most studies reporting outcomes only up to 5 years.
Study Design
This multisite superiority randomized clinical trial was conducted at nine clinical sites within the US Pelvic Floor Disorders Network from April 2013 to February 2015. Inclusion criteria focused on postmenopausal women experiencing symptomatic uterovaginal prolapse. Participants were randomly assigned to undergo either vaginal mesh sacrospinous hysteropexy (n=88) or vaginal hysterectomy with uterosacral ligament suspension (n=87). The primary composite outcome assessing treatment failure was defined as retreatment for prolapse, prolapse extending beyond the hymen on physical exam, or symptomatic prolapse, evaluated over a full decade with time-to-event models. Secondary outcomes included anatomical pelvic organ prolapse quantification measures, validated patient-reported symptoms relating to prolapse, urinary and bowel function, sexual function/dyspareunia, and adverse events. After five years of masked 6-month interval follow-up, unmasked annual assessments continued from years 6 through 10.
Key Findings and Results
A total of 175 participants were analyzed on an intention-to-treat basis with 112 completing the extended 6- to 10-year follow-up. By 10 years, the hysteropexy group demonstrated a significantly lower composite failure rate of 40% (35/88) versus 53% (46/87) for hysterectomy. The adjusted hazard ratio was 0.64 (95% confidence interval [CI], 0.41–1.00; P = .05), indicating a 36% reduction in failure risk with hysteropexy. Both surgical groups sustained durable improvement in prolapse-related symptoms across the decade. No statistically significant differences were observed between groups in bothersome urinary, bowel symptoms, sexual function, or dyspareunia, indicating comparable functional outcomes and patient satisfaction. Importantly, rates of clinically important complications, adverse events, and mesh-related issues were low and did not differ meaningfully between interventions. Although the mesh hysteropexy showed an early advantage in durability, the anticipated further increase in long-term repair robustness beyond year 5 was not evident, suggesting finite longevity benefits of mesh support compared to native tissue repair components.
Interpretation of Results
The results affirm sacrospinous hysteropexy with mesh as a viable uterine-preserving alternative that rivals vaginal hysterectomy in effectiveness and safety over a prolonged postoperative periods. The lower failure risk and comparable symptom relief provide empirical support for offering mesh-augmented hysteropexy to eligible patients wishing to avoid hysterectomy. The data reassure regarding the long-term safety of mesh use in this context, mitigating historical concerns about mesh complications when appropriately performed.
Expert Commentary
The findings align with prior shorter-term studies that suggested benefits of uterine preservation on anatomical outcomes without compromising symptom control. The extended 10-year follow-up enhances clinical confidence in counseling patients on options and reinforces the personalized approach to prolapse surgery. Limitations include the moderate attrition during extended follow-up which may influence generalizability. Further, evolving mesh technology and regulatory environments necessitate cautious extrapolation to newer materials. Future research should continue monitoring very long-term outcomes and explore patient-centered measures such as quality of life and sexual well-being more granularly.
Conclusion
This rigorous, well-controlled trial establishes that sacrospinous hysteropexy with mesh offers a durable, safe, and effective treatment for uterovaginal prolapse at a 10-year horizon, with a lower composite failure rate than vaginal hysterectomy and uterosacral ligament suspension. Both procedures remain appropriate options, allowing surgical plans to be tailored to patient preferences and clinical context. Pragmatic adoption of uterine-sparing mesh-augmented hysteropexy may improve patient satisfaction without compromising long-term outcomes.
Funding and Clinical Trial Registration
The trial was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development within the US Pelvic Floor Disorders Network. Trial registration is available at ClinicalTrials.gov under identifier NCT01802281.
References
1. Nager CW, Visco AG, Richter HE, et al. Sacrospinous Hysteropexy With Mesh vs Vaginal Hysterectomy for Treatment of Uterovaginal Prolapse: 10-Year Results of a Randomized Clinical Trial. JAMA Surg. 2026 Jun 24. PMID: 42340704.
2. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;2013(4):CD004014.
3. Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007;369(9566):1027-1038.
4. Dietz HP, Simpson JM. Pelvic organ prolapse: when is hysterectomy necessary? Obstet Gynecol. 2016;127(3):383-385.