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鄒頡龍 應力性尿失禁患者手術之前的尿路動力學檢查之隨機對照試驗 2012/7/29 下午 04:43:05 0
原 文 題  目 應力性尿失禁患者手術之前的尿路動力學檢查之隨機對照試驗
作  者 Nager CW等人
出  處 New England Journal of Medicine
出版日期 2012 May
評 論 這是由美國NIH機構支持的多醫學中心,隨機取樣研究。對象是單純,沒有其他併發併發症的應力性尿失禁患者。總共有630位女性隨機分組,每一組有315位患者,其中一組在手術前接受尿路動力學檢查,另外一組則否。手術一年後追蹤,接受尿路動力學組手術成功率為76.9%,沒有接受尿路動力學檢查那一組手術成功率為77.2% ,兩者沒用顯著統計學上的差異。結論是:手術前沒有接受尿路動力學檢查並不會影響手術的成果。
雖然這項研究指出手術前的尿路動力學不影響手術結果,但是並不代表尿動力學沒有診斷價值。尤其值得注意的是,這項研究是針對單純的應力性尿失禁的患者,如果患者同時合併有急尿性尿失禁,神經性症狀,或是之前曾經接受過其它尿失禁手術卻失敗的患者,相信尿路動力學檢查還是扮演一定的角色
abstract BACKGROUND
Urodynamic studies are commonly performed in women before surgery for stress
urinary incontinence, but there is no good evidence that they improve outcomes.
METHODS
We performed a multicenter, randomized, noninferiority trial involving women
with uncomplicated, demonstrable stress urinary incontinence to compare outcomes
after preoperative office evaluation and urodynamic tests or evaluation only.
The primary outcome was treatment success at 12 months, defined as a reduction
in the score on the Urogenital Distress Inventory of 70% or more and a response of
“much better” or “very much better” on the Patient Global Impression of Improvement.
The predetermined noninferiority margin was 11 percentage points.
RESULTS
A total of 630 women were randomly assigned to undergo office evaluation with
urodynamic tests or evaluation only (315 per group); the proportion in whom treatment
was successful was 76.9% in the urodynamic-testing group versus 77.2% in
the evaluation-only group (difference, −0.3 percentage points; 95% confidence interval,
−7.5 to 6.9), which was consistent with noninferiority. There were no significant
between-group differences in secondary measures of incontinence severity,
quality of life, patient satisfaction, rates of positive provocative stress tests, voiding
dysfunction, or adverse events. Women who underwent urodynamic tests were significantly
less likely to receive a diagnosis of overactive bladder and more likely to
receive a diagnosis of voiding-phase dysfunction, but these changes did not lead
to significant between-group differences in treatment ion or outcomes.
CONCLUSIONS
For women with uncomplicated, demonstrable stress urinary incontinence, preoperative
office evaluation alone was not inferior to evaluation with urodynamic testing for
outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and
Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health
and Human Development; ClinicalTrials.gov number, NCT00803959.)
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