Quact

作者：Laurie Barclay, MD  
出處：WebMD醫學新聞

　　June 8, 2010 — 根據一項發表於6月3日新英格蘭醫學期刊的大型、多中心、隨機分派相等性研究結果，逆恥骨相較於經閉孔尿道中段吊帶對壓力型尿失禁是一樣有效的。
　　
　　來自伯明罕阿拉巴馬州立大學的Holly E. Richter博士與其來自尿失禁治療網絡的同事們寫到，尿道中段吊帶越來越常用於治療壓力型尿失禁，但是比較不同型式吊帶與相關併發症的數據有限。經閉孔的方法被研發用於減輕與逆恥骨吊帶對膀胱與腸道潛在的傷害，因為吊帶是通過閉孔，避免了逆恥骨空間的骨盆腔器官。
　　
　　這項研究目的在於比較經恥骨與經閉孔尿道中段吊帶對患有壓力型尿失禁女性的效果。主要的試驗終點是12個月後治療成功率，以客觀及主觀標準分析。客觀標準是壓力測試結果陰性，尿布測試結果陰性，且不須接受後續治療，而主觀標準是自我通報的症狀緩解、未記錄到漏尿、且無需後續治療。以差異小於±12%百分比之內作為預先決定的相等性。
　　
　　在隨機分派的597位女性中，565位（94.6%）完成了12個月的評估。逆恥骨吊帶組有80.8%達客觀定義的治療成功，經閉孔吊帶組為77.7%（百分比差異為3.0%；95%信賴區間[CI]為-3.6-9.6）。主觀定義的治療成功分別為62.2%與55.8%（百分比差異為6.4%；95% CI為-1.6-14.3）。
　　
　　接受經閉孔吊帶的受試者沒有任何病患發生需要手術的解尿困難，逆恥骨吊帶組則是2.7%（P=0.004）。神經症狀發生率分別為4.0%與9.4%（P=0.01）。術後急迫尿失禁、手術預後、以及生活品質，兩組的統計是相當的。
　　
　　研究作者們寫到，12個月時客觀評估以逆恥骨或經閉孔方法治療尿失禁治療成功率，達到相等性的預先設定條件；主觀評估的治療成功在兩組之間是相似的，但並未達到相等性的條件。應該和考慮接受外科手術治療尿失禁的病患討論與這兩個術式相關的併發症差異。
　　
　　在隨後的主編評論中，來自阿布奎基新墨西哥大學健康科學中心的Rebecca G. Rogers醫師表示，這項研究的限制在於，僅有一年的後續追蹤，以及可能缺乏對不是那麼具有高度技術外科醫師的應用性。
　　
　　Rogers醫師寫到，引進這樣的新術式通常是根據短期預後，然而病患們要的是短期與長期預後。有三分之一的女性，在她們的一生中接受兩次以上的尿失禁外科手術，有關這兩個術式的長期效果以及相等性，對於做出決定是很重要的，因為這項研究而可能改變的是病患如何接受諮詢，提供與這些手術相關的好處與壞處資訊，讓外科手術選擇最能夠符合病患的目標與期望，還有外科醫師的能力。
　　
　　國家糖尿病與消化、腎臟疾病機構以及國家兒童健康與人類發育機構贊助這項研究。試驗作者們與Rogers醫師的公開事項及全文，刊登在NEJM網站。


Retropubic vs Transobturator Midurethral Slings May Be Equally Effective for Stress Incontinence

By Laurie Barclay, MD
Medscape Medical News

June 8, 2010 — Retropubic or transobturator midurethral slings may be equally effective for stress incontinence, according to the results of a large, multicenter, randomized equivalence trial reported in the June 3 issue of the New England Journal of Medicine.

"Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications," write Holly E. Richter, PhD, MD, from the University of Alabama at Birmingham, and colleagues from the Urinary Incontinence Treatment Network. "The transobturator approach was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator foramen, avoiding the pelvic organs in the retropubic space."

The objective of the study was to compare outcomes with retropubic vs transobturator midurethral slings in women with stress incontinence. The main study endpoint was treatment success at 12 months, defined by objective as well as by subjective criteria. Objective criteria were a negative stress test result, a negative pad test result, and no subsequent treatment, and subjective criteria were self-reported absence of symptoms, no leakage episodes recorded, and no subsequent treatment. Equivalence was predetermined as a difference of no greater than ±12 percentage points.

Of 597 women randomly assigned, 565 (94.6%) completed the 12-month evaluation. Objectively defined treatment success occurred in 80.8% of the retropubic-sling group and in 77.7% of the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], ?3.6 to 9.6). For subjectively defined success, the rates were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, ?1.6 to 14.3).

None of those who received transobturator slings vs 2.7% of those who received retropubic slings experienced voiding dysfunction requiring surgery (P = .004) Rates of neurologic symptoms were 4.0% and 9.4%, respectively (P = .01). The groups were statistically similar in postoperative urge incontinence, satisfaction with the outcome of the procedure, and quality of life.

"The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence," the study authors write. "Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence."

In an accompanying editorial, Rebecca G. Rogers, MD, from the University of New Mexico Health Sciences Center in Albuquerque, notes limitations of follow-up for only 1 year and possible lack of generalizability to less highly skilled surgeons.

"The rationale for the introduction of new surgical procedures is often based on short-term outcomes, whereas patients want both short-term and long-term results," Dr. Rogers writes. "Up to a third of women who have surgery for stress incontinence undergo a second procedure during their lifetime, and data regarding the long-term effectiveness and equivalence of these two procedures are critical to decision making.... What may change [because of this study] is how patients are counseled regarding the benefits and harms associated with the surgery, allowing surgical choices to better match a patient's goals and wishes, as well as the surgeon's abilities."

The National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development supported this study. Disclosure forms provided by the study authors and by Dr. Rogers are available with the full text of this article at the NEJM Web site .

N Engl J Med. 2010;362:2066-2076, 2124-2125.