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临床试验/NCT01054001
NCT01054001Unknown不适用

Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
124
试验地点
1
主要终点
patterns of recovery of erectile functions after nerve sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (using IIEF-5)

研究概览

简要总结

The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after RP).

详细描述

Various studies using animal models of CN neuroparaxia and clinical trials have demonstrated somewhat beneficial effect of PDE-5 inhibitors on smooth muscle cells of the corpus cavernosum. PDE-5 inhibitors including sildenafil have demonstrated the effectiveness in the management of postprostatectomy ED. In the animal experiments, PDE-5 inhibitors lowered the severity of the fibrosis in the corpus cavernosum of rats with CN cutting. In the clinical trials, on-demand dosing or routine dosing of PDE-5 inhibitors improved the potency rates in men received NSRP, and improvements of the potency rate did not appear to be statistically different among two dosing regimens.

But, there are few studies on the potency rate according to the start time of the administration of PDE-5 inhibitors (eg. early vs. delayed post-operative dosing). At present, it is not conclusive that whether nerve-sparing RALP provides more higher potency rate than conventional surgery in men with prostate cancers. But, with more precise dissection of CN, the robotic surgery appears to have more chances to maintain the potency in men received RP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients with agree to participate with the study
  • Korean male subjects aged 50 years or older with clinically localized prostate cancer
  • Preoperative potent men (IIEF-5 score 17 or more than 17)
  • Patients in a stable, heterosexual relationship with a single partner for at least the past six months
  • Suitable for nerve sparing indication

排除标准

  • Genital anatomical deformities that would significantly impair erection
  • Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.
  • Known raised prolactin level (>3 times the upper limit of the normal range) or low free testosterone level (confirmed to be >20% below the lower limit of the normal range on blood collected between 09:00 and 11:00 hours).
  • Major psychiatric disorder (including major depression or schizophrenia) that is not well controlled on treatment.

研究组 & 干预措施

Early

Active Comparator

men with on- demand sildenafil 100mg dosing from the early postoperative period

干预措施: sildenafil 100mg (Drug)

Delayed

Active Comparator

men with on- demand sildenafil 100mg dosing from the delayed postoperative period

干预措施: sildenafil 100mg (Drug)

结局指标

主要结局

patterns of recovery of erectile functions after nerve sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (using IIEF-5)

时间窗: 1 year

次要结局

  • comparison of the potency rates in men with on- demand sildenafil 100mg dosing from the early postoperative period with from the delayed postoperative period(2 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Eun Lee

Professor

Seoul National University Bundang Hospital

研究点 (1)

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