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首页> 外文期刊>BJU international >A double-blind, randomized, placebo-controlled pilot study to investigate the effects of finasteride combined with a biodegradable self-reinforced poly L-lactic acid spiral stent in patients with urinary retention caused by bladder outlet obstruction
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A double-blind, randomized, placebo-controlled pilot study to investigate the effects of finasteride combined with a biodegradable self-reinforced poly L-lactic acid spiral stent in patients with urinary retention caused by bladder outlet obstruction

机译：一项双盲，随机，安慰剂对照的前瞻性研究，以研究非那雄胺联合可生物降解的自增强聚L-乳酸螺旋支架在膀胱出口阻塞引起的尿retention留中的作用

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OBJECTIVE: To assess whether patients in acute urinary retention from benign prostatic enlargement can be treated with a combined therapy comprising finasteride and a bioabsorbable self-reinforced poly L-lactic acid (SR-PLLA) urethral stent. PATIENTS AND METHODS: Fifty-five patients in acute urinary retention were treated as outpatients; they had a suprapubic catheter inserted and the SR-PLLA stent placed cystoscopically. After 2 weeks the patients were randomized to receive either finasteride 5 mg daily or placebo. They were assessed at baseline and at 6, 12 and 18 months for maximum urinary flow rate, prostate volume and serum prostate-specific antigen (PSA). RESULTS: Nineteen patients completed the study while 36 discontinued. There was a statistically significant increase in the mean maximum flow rate, and a statistically significant decrease in the prostatic volume and serum PSA in the finasteride group. The same number of patients discontinued in both groups; the major reason for discontinuation was insufficient therapeutic response. CONCLUSIONS: The major problems were discontinuation of treatment because the response to therapy was insufficient, and uncontrolled breakdown of the spiral stent. To solve these problems, new configurations of bioabsorbable stents are needed.
机译：目的：为了评估因良性前列腺肿大而导致急性尿with留的患者是否可以采用包括非那雄胺和可生物吸收的自增强聚L-乳酸（SR-PLLA）尿道支架的联合疗法进行治疗。病人和方法：将55例急性尿retention留患者作为门诊患者。他们插入了耻骨上导管，并在膀胱镜下放置了SR-PLLA支架。 2周后，患者随机接受每日5 mg非那雄胺或安慰剂治疗。在基线，第6、12和18个月时评估他们的最大尿流率，前列腺体积和血清前列腺特异性抗原（PSA）。结果：19名患者完成了研究，而36名患者终止了研究。非那雄胺组的平均最大流速在统计学上显着增加，而前列腺体积和血清PSA则在统计学上显着下降。两组中停药的患者数量相同;停药的主要原因是治疗反应不足。结论：主要问题是由于对治疗的反应不足而终止治疗，以及螺旋支架的失控。为了解决这些问题，需要生物可吸收支架的新构造。

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