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李宗叡 單一切口中段陰道迷你吊帶術應用於婦女應力性尿失禁手術的3年效果 2024/5/23 下午 07:50:41 0
原 文 題  目 Single-Incision Mini-Slings for Stress Urinary Incontinence in Women
作  者 Mohamed Abdel-Fattah, M.D., David Cooper, Ph.D., Tracey Davidson, M.Sc., Mary Kilonzo, M.Sc., Md Hossain, Ph.D., Dwayne Boyers, Ph.D., Kiron Bhal, M.D., Judith Wardle, Ph.D., James N’Dow, F.R.C.S.(Urol.), Graeme MacLennan, M.Sc., and John Norrie, M.Sc.
出  處 N Engl J Med, 2022. 386: 1230
出版日期 March 30, 2022
評 論

尿道中段懸吊手術對於應力性尿失禁的治療效果已有文獻指出可長達15年,然而新型的單一切口中段陰道迷你吊帶手術目前追蹤時間較短,既有文獻對於其長期效果仍抱持期待。這項研究是隨機分布,比較了英國的女性使用迷你吊帶和中尿道吊帶,術後追蹤其治療效果長達3年。患者在15個月後透過 PGI-I questionnaire填答,使用迷你吊帶的患者中,有212名(79.1%)覺得治療成功(定義為顯著改善或很有改善);而使用中尿道吊帶的患者中,有189名(75.6%)覺得治療成功。在術後36個月時,兩組的成功率分別為72.0%和66.8%,皆未達顯著差異。關於不良事件發生的比較,兩組之間的腹股溝或大腿疼痛情況相似(迷你吊帶組為14.1%,中尿道吊帶組為14.9%)。迷你吊帶組的網膜暴露發生率為3.3%,中尿道吊帶組為1.9%,而術後需要再次接受尿失禁手術的比例分別為2.5%和1.1%。在除性交疼痛外,生活質量和性功能滿意度兩組相似。迷你吊帶組在36個月後有11.7%的患者有性交疼痛,而中尿道吊帶組為4.8% (p =0.01)。總體而言,迷你吊帶手術在15個月和36個月時的患者報告成功率上都不遜於中尿道吊帶手術。在不良事件發生率方面也相似,除了迷你吊帶組出現較高比例的性交疼痛。

abstract

Background
Long-term data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited.

Methods
We performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization.

Results
A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], −2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, −1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group.

Conclusion
Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up.

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