A prospective, randomized, placebo-controlled trial of on-Demand vs. nightly sildenafil citrate as assessed by Rigiscan and the international index of erectile function
A prospective, randomized, placebo-controlled trial of on-Demand vs. nightly sildenafil citrate as assessed by Rigiscan and the international index of erectile function
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DOI：
10.1111/andr.12118
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发表时间：
2016-01-01
期刊：
影响因子：
4.5
通讯作者：
Dean, R. C.
中科院分区：
文献类型：
--
作者：
Kim, D. J.;Hawksworth, D. J.;Dean, R. C.
多项研究评估了PDE5抑制剂在保留神经的前列腺切除术后阴茎康复中的应用。这些研究评估了各种药理制剂的使用以及各种治疗方法(按需治疗与康复治疗)。这些研究中的大多数依赖于自我报告的结果来确定治疗的有效性，这可能会允许反应偏差影响他们的结果。这项研究的目的是除了IIEF-EF外，还使用夜间阴茎刚性(RigiScan(TM)，Gotop Medical，Inc.，St.Paul，MN，USA)来评估夜间柠檬酸西地那非治疗阴茎康复的效果。在NSRP之前，有局限性前列腺癌和勃起功能正常的患者被随机分成两组，从手术后的第二天晚上开始，每晚服用50毫克的柠檬酸西地那非或安慰剂。两组都被允许按需服用柠檬酸西地那非。分别于术后2周、3、6、9、12个月进行勃起功能评估，13个月时评估勃起功能，1个月后进行药物冲洗。在所有时间点，获得并评估自我报告(IIEF-EF)和目标(RigiScan(TM))测量。97名随机患者中约有74人完成了这项研究。完成后，根据RigiScan TM，每组均有40%的患者勃起功能正常(p=1.0)。此外，使用IIEF-EF领域没有发现统计学差异(安慰剂组32.4%，治疗组29%；p=0.79)。多变量分析显示，基于治疗干预的勃起功能无显著差异。结果确实表明，随着时间的推移，该队列中的非裔美国人男性患RigiScan TM分数较低的风险更高(OR：0.48，p=0.0399)。这项研究表明，与使用自我报告和客观措施的按需给药相比，夜间服用柠檬酸西地那非对前列腺癌切除术后勃起功能的恢复没有提供治疗上的好处。基于患者种族/民族的客观康复参数的差异值得进一步调查。
Multiple studies have evaluated the use of PDE5 inhibitors in penile rehabilitation following nerve-sparing prostatectomy. These studies have evaluated the use of various pharmacologic agents as well as various approaches to treatment (on-demand vs. rehabilitative). Most of these studies relied on self-reported outcomes to determine efficacy of the therapy which could allow response bias to affect their results. The aim of this study was to evaluate the effects of nightly sildenafil citrate therapy during penile rehabilitation, using nocturnal penile rigidity (RigiScan (TM), Gotop Medical, Inc., St. Paul, MN, USA) in addition to the IIEF-EF. Patients with localized prostate cancer and normal erectile function prior to nsRP were randomized to take either nightly 50 mg sildenafil citrate or placebo starting the night following surgery. Both groups were allowed on-demand sildenafil citrate. Erectile function was evaluated at 2 weeks, 3, 6, 9 and 12 months post-operatively, with a final assessment made at 13 months, following a 1 month drug washout. At all time points, self-reported (IIEF-EF) and objective (RigiScan (TM)) measures were obtained and evaluated. About 74 of 97 randomized patients completed the study. On completion, 40% of patients in each group had normal erectile function based on RigiScan TM (p = 1.0). Additionally, no statistical differences were seen using the IIEF-EF domain (32.4% of placebo, 29% of treatment; p = 0.79). Multivariable analysis showed no significant differences in erectile function based on treatment intervention. Results did show that African-American men in this cohort were at higher risk for lower RigiScan TM scores over time (OR: 0.48, p = 0.0399). This study demonstrates that nightly sildenafil citrate does not provide a therapeutic benefit for recovery of erectile function post-prostatectomy when compared to on-demand dosing using both self-reported as well as objective measures. Differences in objective recovery parameters based on patients' race/ethnicity warrant further investigation.