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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 高銘鴻 | 前瞻性研究:單一切口尿道吊帶與經閉鎖孔吊帶手術治療應力型尿失禁病人三年的比較結果 | 2021/3/30 下午 07:07:07 | 0 |
| 原 文 | 題 目 | Prospective study of a single-incision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results |
| 作 者 | Amanda B White, Bruce S Kahn, Ricardo R Gonzalez | |
| 出 處 | American Journal of Obstetrics & Gynecology | |
| 出版日期 | 2020 Oct;223(4):545.e1-545.e11 | |
| 評 論 |
尿道中段吊帶手術改善女性應力型尿失禁手術已被應用數十年，一開始將合成吊帶經恥骨固定於下腹(TVT)，後來於2001年後經閉鎖孔尿道吊帶手術(TVT-O)也進入改善應力型尿失禁的領域，TVT-O 帶來的好處在於降低術中膀胱破裂的風險與其他的併發症。但TVT-O也帶來早期術後大腿內側的疼痛感，以及稍微較高再手術率，但是整體發生機率不高。 而後來單一切口吊帶手術(SIS)則類似了TVT-O的手術方式，只是沒有全部穿越閉鎖孔同時也不會穿出皮膚，可以改善大腿疼痛感與保留大腿內側美觀。但因為因為只有部分固定於閉鎖孔的組織，大家對於長期效果是否能與TVT-O類似則保有懷疑。而本篇則是一個追蹤三年的前瞻性研究來比較TVT-O與SIS的效果，比較了同一家公司(Boston Scientific)的TVT-O與SIS產品，在第36個月時SIS的成功率為90.4%，TVT-O的成功率為88.9%，兩者成功率長時間的成功率相仿，而在手術中出血量、住院天數、術後自行解尿的時間，兩者也是相近。而併發症如性交疼痛、骨盆腔疼痛或是網膜裸露等等，兩者之間都沒有統計上的顯著差異。 因此，這篇論文帶給我們的資訊是，在長時間的比較後，SIS在治療對應力型尿失禁並不會遜色於TVT-O。從社會學家馬斯洛的需求金字塔來看，最低層到最高層分別是:生理需求、安全需求、社會需求、尊重需求、自我實現。而治療應力型尿禁最基本的是改善漏尿，處於社會需求或尊重需求層次，而隨著社會的演變，對於美感的需求也逐漸上升，因次是否在身上留下傷疤則逐漸成為重要的問題。在臨床上，我們也應與病人進行醫療與個人美感需求的討論，而尋求對病人最好的治療。 |
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| abstract |
Background: Long-term safety and efficacy data on use of single-incision slings in stress urinary incontinence are limited.
Objective: To determine whether the single-incision sling Solyx (Boston Scientific, Marlborough, MA) is noninferior to the transobturator sling Obtryx II (Boston Scientific) in efficacy and safety for treatment of stress urinary incontinence. This 522 post-market surveillance study has been designed in response to a Food and Drug Administration request to evaluate improvement in stress urinary incontinence at 36 months following single-incision sling compared with baseline, as well as provide an assessment of mesh-related complications and subject-reported outcomes, relative to the transobturator sling control. Study design: This prospective, nonrandomized, parallel cohort, multicenter postapproval study enrolled subjects to receive single-incision sling or transobturator sling. Study sites were assigned to a cohort group based on documented competency with the cohort device. Patient follow-up was 36 months to compare efficacy and adverse events for noninferiority. Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test, and post-void residual ≤150 cc. Participants were ineligible if they had undergone previous stress urinary incontinence surgery or had a previous mesh complication. Primary endpoint was treatment success defined by composite negative cough stress test and subjective improvement in stress urinary incontinence using Patient Global Impression of Improvement at 36 months. Secondary endpoints included adverse events and indications for retreatment. Noninferiority margins of 15% and 10% were prespecified for the primary efficacy and safety endpoints. Data analysis was performed using intent-to-treat and per-protocol methods. Due to the observational nature of the study, a propensity score methodology was applied to account for differences in patient and surgeon characteristics between treatment groups. The study design and variables to be included in the propensity score model were reviewed and approved by Food and Drug Administration reviewers before outcome analyses were performed. Results: No evidence of imbalance in baseline characteristics was observed between groups after propensity score stratification in the 281 subjects. EBL (72.3±92 vs 73.1±63.9 mL, P=.786), time to spontaneous void (1.1±2 vs 0.8±2.8 days, P=.998), and time to discharge (0.7±0.7 vs 0.6±0.6 days, P=.524) were similar between groups. At 36 months, treatment success was 90.4% in the single-incision sling group and 88.9% in the transobturator sling group (P=.93). At 36 months, mesh-related complications were similar between groups (mesh exposure: 2.8% vs 5.0%, P=.38). Serious adverse events including pain during intercourse (0.7% vs 0%, P=1.00), pelvic pain (0.7% vs 0%, P=1.00), and urinary retention (2.8% vs 4.3%, P=.54) were similar between groups. Conclusion: Single-incision sling was not inferior to transobturator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events were acceptably low and similar between groups. |
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