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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 盧令一 | 應力性尿失禁該手術還是物理治療？ | 2013/10/23 上午 10:28:57 | 0 |
| 原 文 | 題 目 | Surgery versus Physiotherapy for Stress Urinary Incontinence |
| 作 者 | Julien Labrie, M.D etc. | |
| 出 處 | N Engl J Med. 2013;369:1124-1133 | |
| 出版日期 | September 19, 2013 | |
| 評 論 |
以往對於應力性尿失禁的治療方式，無論是手術或是物理治療，總是各有擁護者，由於沒有大型的隨機對照試驗來比較兩種治療方式孰優，臨床上常會建議病患先嘗試物理治療，等病患學會控制骨盆底肌或是治療效果不彰，才考慮手術治療。 荷蘭的研究計畫針對這個問題聯合18家醫院21位醫師設計了大型的隨機對照試驗，將460位中度至重度應力性尿失禁且從未手術治療過的病患隨意分為手術（mid-urethral mesh sling, transobturator or retropubic technique）及物理治療二組，並允許病患如不滿意物理治療結果，可轉至手術組治療。治療後追蹤一年的結果認為，無論主觀或是客觀的評估，以手術治療應力性尿失禁的結果均明顯優於物理治療的結果（90.8% vs. 64.4%），先做物理治療再手術與直接手術的結果統計比較上並沒有差異。當然物理治療組沒有發生任何不良事件（adverse event），而手術組的不良事件發生率則超過一成。 作者建議臨床醫師對於應力性尿失禁的治療，還是要將兩種治療方式的優劣讓病患了解，否則這個結論可能導致醫師及病患跳過物理治療，直接選擇以手術方式治療應力性尿失禁。 AUA發言人Tomas Griebling, MD（from the University of Kansas in Kansas City）則是對於這篇文章的結論提出三項意見： 一、 美國FDA已經針對人工合成網膜應用在應力性尿失禁及骨盆器官脫垂的治療上可能造成嚴重的併發症於2008十月及2011七月兩次提出警示，並仍持續觀察中； 二、 很多文獻顯示以物理治療治療應力性尿失禁有非常好的效果； 三、 這篇文章的實驗設計無法做到雙盲（bouble-blind），所以手術組的placebo effect是可能發生的。 |
|
| abstract |
BACKGROUND Physiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy. METHODS We performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months. RESULTS We randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery. CONCLUSIONS For women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.) |
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