JAMA surgery · 2026
Sacrospinous Hysteropexy With Mesh vs Vaginal Hysterectomy for Treatment of Uterovaginal Prolapse: 10-Year Results of a Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Nager Charles W, Visco Anthony G, Richter Holly E, Rardin Charles R, Meriwether Kate, Harvie Heidi S, Zyczynski Halina M, Paraiso Marie Fidela R, Mazloomdoost Donna, Sridhar Amaanti, Thomas Sonia, Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network
Аннотация
IMPORTANCE: Vaginal hysterectomy with suture apical suspension (hysterectomy) is commonly performed for uterovaginal prolapse, and a vaginal sacrospinous hysteropexy with graft (hysteropexy) is a uterine-sparing alternative. Ten-year outcomes for prolapse surgeries are rarely reported.
OBJECTIVE: To compare the efficacy and adverse events of these 2 procedures over 10 years.
DESIGN, SETTING, AND PARTICIPANTS: At 9 clinical sites in the US Pelvic Floor Disorders Network, postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a multisite superiority randomized clinical trial between April 2013 and February 2015. Study data were analyzed from February 2018 to November 2025.
INTERVENTIONS: Women were originally randomized to vaginal mesh hysteropexy or to vaginal hysterectomy with uterosacral ligament suspension. Participants had 5 years of masked follow-up at 6-month intervals followed by an extended unmasked annual follow-up from 6 to 10 years.
MAIN OUTCOMES AND MEASURES: The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with time-to-failure models. Secondary outcomes included individual anatomic Pelvic Organ Prolapse Quantification measures, bothersome symptoms measured by validated questionnaires, complications and adverse events.
RESULTS: A total of 183 participants (mean [SD] age, 66 [7] years) were randomized, and 175 were included in the intention-to-treat analysis after ineligibility exclusions (88 hysteropexy group and 87 hysterectomy group), 112 of whom (64%; 55 hysteropexy group and 57 hysterectomy group) participated in the 6- to 10-year follow-up extension. There were fewer failures for hysteropexy (35 of 88 [40%]) compared with hysterectomy (46 of 87 [53%]) through 10 years. Time-to-failure analysis showed lower failure risk in hysteropexy (adjusted hazard ratio, 0.64; 95% CI, 0.41-1.00; P = .05). Both groups had sustained improvements in patient reported outcomes with no group differences demonstrated in patient-reported prolapse, urinary, or bowel symptoms, sexual function, dyspareunia, or clinically important complications.
CONCLUSIONS AND RELEVANCE: Results show that vaginal mesh hysteropexy continued to have a lower composite failure rate through 10 years than vaginal hysterectomy with uterosacral ligament suspension, although an expected increase in durability over the native tissue procedure in years 6 to 10 was not observed. Both procedures are reasonable options for patients. If available, hysteropexy with mesh augmentation for patients who desire uterine preservation is a low risk and effective option.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01802281.
OBJECTIVE: To compare the efficacy and adverse events of these 2 procedures over 10 years.
DESIGN, SETTING, AND PARTICIPANTS: At 9 clinical sites in the US Pelvic Floor Disorders Network, postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a multisite superiority randomized clinical trial between April 2013 and February 2015. Study data were analyzed from February 2018 to November 2025.
INTERVENTIONS: Women were originally randomized to vaginal mesh hysteropexy or to vaginal hysterectomy with uterosacral ligament suspension. Participants had 5 years of masked follow-up at 6-month intervals followed by an extended unmasked annual follow-up from 6 to 10 years.
MAIN OUTCOMES AND MEASURES: The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with time-to-failure models. Secondary outcomes included individual anatomic Pelvic Organ Prolapse Quantification measures, bothersome symptoms measured by validated questionnaires, complications and adverse events.
RESULTS: A total of 183 participants (mean [SD] age, 66 [7] years) were randomized, and 175 were included in the intention-to-treat analysis after ineligibility exclusions (88 hysteropexy group and 87 hysterectomy group), 112 of whom (64%; 55 hysteropexy group and 57 hysterectomy group) participated in the 6- to 10-year follow-up extension. There were fewer failures for hysteropexy (35 of 88 [40%]) compared with hysterectomy (46 of 87 [53%]) through 10 years. Time-to-failure analysis showed lower failure risk in hysteropexy (adjusted hazard ratio, 0.64; 95% CI, 0.41-1.00; P = .05). Both groups had sustained improvements in patient reported outcomes with no group differences demonstrated in patient-reported prolapse, urinary, or bowel symptoms, sexual function, dyspareunia, or clinically important complications.
CONCLUSIONS AND RELEVANCE: Results show that vaginal mesh hysteropexy continued to have a lower composite failure rate through 10 years than vaginal hysterectomy with uterosacral ligament suspension, although an expected increase in durability over the native tissue procedure in years 6 to 10 was not observed. Both procedures are reasonable options for patients. If available, hysteropexy with mesh augmentation for patients who desire uterine preservation is a low risk and effective option.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01802281.