Dinsmore Wallace W, Ralph David J, Kell Phillip, Wylie Kevan R, Dean John P, Novak Claire, Wyllie Jennifer S, Wyllie Michael G
Royal Victoria Hospital, Belfast.
BJU Int. 2006 Sep;98(3):613-8. doi: 10.1111/j.1464-410X.2006.06286.x.
To validate the Sexual Assessment Monitor (SAM), a novel apparatus designed to collect electronic data on ejaculatory latency time (ELT) for diagnosing premature ejaculation (PE), and for accurately measuring treatment outcomes in clinical trials.
PATIENTS, SUBJECTS AND METHODS: Men with PE, and healthy volunteers aged 18-75 years, were enrolled in three open-label studies, conducted in the UK. The SAM, which consists of a control box with two front attachments, a vibrator and sensor, was attached to the penis. The vibrator, which provides stimulation, was positioned at the frenulum using a soft cuff; the vibrator intensity was set at 80 units for most subjects. The sensor is an indium-gallium elasticated loop, which was positioned around the base of the penis to detect ejaculatory pulses. These pulses were transmitted to a data recorder in the control box. The data, which are displayed graphically as traces, were automatically classified by a computer-generated algorithm to quantify ELT.
In all, 53 healthy volunteers and 58 men with PE provided 213 and 195 evaluable records, respectively. Most were complete records (99% and 96%). The pooled data showed that the ELT was much higher for healthy volunteers than for men with PE (geometric means: 687 vs 169 s, respectively), with a healthy volunteer to PE patient ratio of 2.87 (P < 0.001). Only 6.3% of subjects reported mild adverse events, which were unrelated to the SAM.
These open-label studies show that the SAM can consistently and safely measure times to erection (from the start of vibration) and ejaculation, and ELT in healthy volunteers and men with PE. These findings show that the SAM has the potential to become the 'gold standard' in the diagnosis of PE and in clinical trials design.
验证性评估监测仪（SAM），这是一种旨在收集射精潜伏期（ELT）电子数据以诊断早泄（PE）并在临床试验中准确测量治疗效果的新型仪器。
患者、受试者与方法：患有早泄的男性以及18 - 75岁的健康志愿者参与了在英国进行的三项开放标签研究。SAM由一个带有两个前部附件的控制盒、一个振动器和传感器组成，被附着于阴茎上。提供刺激的振动器通过一个软袖带放置在系带处；大多数受试者的振动器强度设定为80单位。传感器是一个铟镓弹性环，环绕在阴茎根部以检测射精脉冲。这些脉冲被传输到控制盒中的数据记录器。以图形轨迹形式显示的数据由计算机生成的算法自动分类以量化ELT。
总共，53名健康志愿者和58名患有早泄的男性分别提供了213份和195份可评估记录。大多数是完整记录（分别为99%和96%）。汇总数据显示，健康志愿者的ELT远高于患有早泄的男性（几何均值分别为687秒和169秒），健康志愿者与早泄患者的比例为2.87（P < 0.001）。仅6.3%的受试者报告了轻度不良事件，且这些事件与SAM无关。
这些开放标签研究表明，SAM能够持续且安全地测量健康志愿者和患有早泄的男性从振动开始到勃起和射精的时间以及ELT。这些发现表明，SAM有潜力成为早泄诊断和临床试验设计中的“金标准”。
