Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies

Abstract

OBJECTIVETo 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 METHODSMen with PE, and healthy volunteers aged 18-75 years, were enrolled in three openlabel 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 indiumgallium 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. RESULTSIn 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. CONCLUSIONSThese 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.

Premature ejaculation

“…Laboratory studies of ejaculatory dysfunction may be simplified by the use of the Sexual Assessment Monitor (SAM), an electronic data collector which comprises a vibrator to induce ejaculation and a sensor to measure time-to-erection and IELT by the detection of ejaculatory pulses, but the role of such devices in large at-home Phase III clinical trials is limited. [69] Recent normative IELT data supports earlier suggestions by several authors that intravaginal ejaculatory latency times (IELTs) of less than 1 minute or less than 2 minutes be regarded as cut-points for inclusion in a clinical trial. [92740] Subjective patient reported outcomes (PROs) of ejaculatory control, sexual satisfaction and bother/distress are important additional efficacy endpoints and can be evaluated using validated patient reported outcome instruments.…”

Clinical Trial Methodology in Premature Ejaculation Observational, Interventional, and Treatment Preference Studies—Part I—Defining and Selecting the Study Population

“…The IELT, AELT, OELT, and MELT can be estimated by the subject or can be measured with a stopwatch operated by the female partner, is expressed in seconds or minutes, and in cases of anteportal ejaculation, is equal to zero. In laboratory studies of ejaculatory dysfunction, MELT can be measured with the Sexual Assessment Monitor, an electronic data collector that comprises a vibrator to induce ejaculation and a sensor to measure time‐to‐erection and MELT by the detection of ejaculatory pelvic floor muscle contractions [31].…”

Ejaculatory disorders: pathophysiology and management

“…A novel apparatus has been designed and validated to collect electronic data on IELT, called the Sexual Assessment Monitor (SAM). Dinsmore et al 56 showed that the SAM is able to measure effectively and safely the time to ejaculation from the start of vibration in healthy volunteers and men with PE. The authors concluded that the SAM has the potential to become the gold standard for the diagnosis of PE, as well as in the design of clinical trials.…”