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吳俊賢 婦女應力性尿失禁病患在接受手術前是否需施行尿路動力學檢查? 2012/9/27 下午 01:16:26 0
原 文 題  目 Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial
作  者 S.A.L. van Leijsen, K.B. Kluivers, B.W.J. Mol, S.R. Broekhuis, A.L. Milani, M.Y. Bongers, C.I.M. Aalders, V. Dietz, G.G. A. Malmberg, M.E. Vierhout, J.P.F.A. Heesakkers
出  處 Neurourol. Urodynam. 31:1118–1123, 2012
出版日期 2012年9月
評 論   婦女應力性尿失禁 (stress urinary incontinence, SUI)病患若接受保守治療 (包含藥物治療及骨盆底肌肉復健治療)療效不佳,則應考慮手術治療,但在接受手術前是否需接受尿路動力學檢查以確定診斷目前仍有爭議,之前的系統性文獻回顧(systemic review)文章建議應施行隨機分佈的試驗(randomized trial)以確定術前尿路動力學檢查是否能提高術後尿失禁症狀改善比例。本篇文章是第一篇採隨機分佈的試驗來探討術前尿路動力學檢查之價值的研究。

  其研究結果發現婦女應力性尿失禁接受保守治療成效不佳的病患,在考慮接受手術治療前不管是否施行尿路動力學檢查確定尿失禁的診斷,術後尿失禁的改善比例並無統計學上的差異,亦即醫師經由病史、理學檢查及解尿日記來診斷應力性尿失禁並建議病患接受手術,其術後結果並不比進一步接受尿路動力學檢查的病患差。

  在這項研究中,31位臨床上診斷為應力性尿失禁的病患接受尿路動力學檢查以確定診斷,但卻有15位 (佔48%) 病患於檢查中無法重現應力性尿失禁,因此在這群接受尿路動力學檢查的病患,有較高的比率延遲或沒有接受手術治療。這個發現點出尿路動力學檢查的限制,亦即醫師試圖經由檢查了解病患的下尿路功能,但畢竟尿路動力學檢查是一種侵入性檢查,檢查時的下尿路功能和病患日常生活時的情形無法完全相同,病患可能因尿道中置放導尿管、或因檢查時情緒緊繃以至於骨盆腔肌肉張力變強而無法重現應力性尿失禁的症狀,因此造成偽陰性(false negative)的檢查結果。

  雖然這個研究發現術前不管有無施行尿路動力學檢查,術後尿失禁改善情形並無差異,但參與試驗的病患人數不多(共計59人),仍需更大規模的研究來佐證此研究結論。而針對尿失禁的診斷和治療,主要仍需有經驗的醫師,綜合所有的臨床資訊,才能提供病患適切的建議和治療。
abstract Aims
To assess in women with stress urinary incontinence (SUI) the value of urodynamics prior to treatment.

Methods
We performed a multicenter non-inferiority randomized controlled trial. Women with SUI were randomly allocated to management based on a workup with or without urodynamics. The primary outcome was clinical reduction of complaints as measured with the Urogenital Distress Inventory urinary incontinence subscale (UDI-UI) at 12 months after the onset of treatment. A mean difference in improvement of less than 8 was considered non-inferior. The study was analyzed according to intention-to-treat.

Results
The trial was stopped prematurely because of slow recruitment. We randomly allocated 59 women to a strategy with (N = 31) or without (N = 28) urodynamics. The mean difference in improvement on the UDI-UI was 14 in favor of the group without urodynamics (48 SD ± 22 vs. 34 SD ± 22, 95% CI: −28 to −0.26), confirming non-inferiority. Addition of urodynamics did not result in a lower occurrence of de novo overactive bladder complaints compared to a workup without urodynamics (6/31 vs. 1/28; RR 5.4, 95% CI: 0.70–42). In the group allocated to urodynamics, initial surgical management was more often abandoned compared to the group not allocated to urodynamics (5/31 vs. 1/28; RR 4.5, 95% CI: 0.56–36).

Conclusions
In this relatively small study, the omission of urodynamics was not inferior to the use of urodynamics in the preoperative workup of women with SUI. Women with SUI undergoing urodynamics had the risk of a choice for more prudent treatment, which seemed to result in a delay until effective treatment.
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