Background: Currently available evaluation criteria for penile tumescence and rigidity have been fraught with controversy. In this study, we sought to establish normative Chinese evaluation criteria for penile tumescence and rigidity by utilizing audiovisual sexual stimulation and RigiScan™ test (AVSS-Rigiscan test) with the administration of phosphodiesterase-5 inhibitor.
Methods: A total of 1169 patients (aged 18-67 years) complained of erectile dysfunction (ED) underwent AVSS-RigiScan test with the administration of phosphodiesterase-5 inhibitor. A total of 1078 patients whose final etiological diagnosis was accurate by means of history, endocrine, vascular, and neurological diagnosis, International Index of Erectile Function 5 questionnaire, and erection hardness score were included in the research. Logistic regression model and receiver operating characteristic curve analysis were performed to determine the cutoff value of the RigiScan™ data. Then, the multivariable logistic analysis was used in the selected variables.
Results: A normal result is defined as one erection with basal rigidity over 60% sustained for at least 8.75 min, average event rigidity of tip at least 43.5% and base at least 50.5%, average maximum rigidity of tip at least 62.5% and base at least 67.5%, △tumescence (increase of tumescence or maximum-minimum tumescence) of tip at least 1.75 cm and base at least 1.95 cm, total tumescence time at least 29.75 min, and times of total tumescence at least once. Most importantly, basal rigidity over 60% sustained for at least 8.75 min, average event rigidity of tip at least 43.5%, and base at least 50.5% would be the new normative Chinese evaluation criteria for penile tumescence and rigidity. By multivariable logistic regression analysis, six significant RigiScan™ parameters including times of total tumescence, duration of erectile episodes over 60%, average event rigidity of tip, △tumescence of tip, average event rigidity of base, and △tumescence of base contribute to the risk model of ED. In logistic regression equation, predict value P < 0.303 was considered as psychogenic ED. The sensitivity and specificity of the AVSS-RigiScan test with the administration of phosphodiesterase-5 inhibitor in discriminating psychogenic from organic ED was 87.7% and 93.4%, respectively.
Conclusions: This study suggests that AVSS-RigiScan test with oral phosphodiesterase-5 inhibitors can objectively assess penile tumescence and rigidity and seems to be a better modality in differentiating psychogenic from organic ED. However, due to the limited sample size, bias cannot be totally excluded.
视听觉性刺激Rigiscan诊断勃起功能障碍摘要背景：目前现有的勃起硬度评价标准仍存在较大的争议，本研究旨通过口服PDE5抑制剂联合视听觉性刺激Rigiscan（AVSS-Rigiscan）建立中国人群勃起硬度的正常参考值。 方法：1169例18-67岁的勃起功能障碍（ED）患者予口服磷酸二酯酶-5（PDE5）抑制剂并行AVSS-RigiScan实时监测阴茎勃起情况，并通过病史采集、内分泌学、血管功能和神经系统检测、国际勃起功能指数5（IIEF-5）问卷以及勃起硬度评分（EHS）作出病因学诊断。Logistic回归模型和受试者工作特征曲线（ROC）分析用于确定RigiScan™各参数的截断值，选择变量采用多因素Logistic回归分析。 结果：RigiScan™各参数的正常参考值下限分别为：阴茎基底部充分勃起（平均勃起硬度>60%）持续时间8.75min、冠状沟部平均硬度43.5%、基底部平均硬度50.5%、冠状沟平均最大硬度62.5%、基底部平均最大硬度67.5%、冠状沟部肿胀增加值1.75cm、基底部肿胀增加值1.95cm、总勃起时间29.75min、勃起次数1次，其中基底部充分勃起（平均勃起硬度>60%）时间8.75min、冠状沟部平均硬度43.5%和基底部平均硬度50.5%可作为中国人群勃起硬度的新的正常参考值。通过多因素Logistic回归分析显示，基底部充分勃起持续时间、冠状沟部平均硬度、冠状沟部肿胀增加值、基底部平均硬度及基底部肿胀增加值等6个RigiScan™参数可作为ED风险预测模型的重要指标，即当Logistic回归方程的预测值P<0.303时诊断为心理性ED，反之为器质性ED。口服PDE5抑制剂联合AVSS-Rigiscan鉴别诊断心理性和器质性ED的灵敏度和特异度分别为87.7%和93.4%。 结论：本研究表明，通过口服PDE5抑制剂联合AVSS-Rigiscan能更好、更客观地鉴别诊断心理性和器质性ED，但由于本研究样本量有限，偏倚仍不能完全排除。.
Keywords: Audiovisual Sexual Stimulation-RigiScan Test; Erectile Dysfunction; Phosphodiesterase-5 Inhibitor.