Female pelvic medicine & reconstructive surgery · 2013
Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.
СтатьяМногоцентровое исследованиеНазвание 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.
Stanford Edward J, Moore Robert D, Roovers Jan-Paul W R, Courtieu Christophe, Lukban James C, Bataller Eduardo, Liedl Bernhard, Sutherland Suzette E
Аннотация
OBJECTIVE: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up.
METHODS: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis.
RESULTS: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001).
CONCLUSIONS: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.
METHODS: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis.
RESULTS: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001).
CONCLUSIONS: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.