Evaluation of the Safety and Effectiveness of the vPatch Device

After the first visit the Patients will undergo a run-in Home Phase, during which they will be asked to have 4 sexual intercourse sessions with their female partners, in the privacy of their home, during which their partner will measure their intravaginal ejaculatory latency time (IELT) using a stopwatch.

After the run-in Home Phase the Patients will be requested to attend to the hospital (Visit 2) and the ones with a IELT value confirming their eligibility will be randomized in the trial (otherwise they will be excluded as Screening Failures).

Visit 2 will include three steps. Step 1: conditioning stimulation, delivered to the Patient's forearm muscles, aiming at familiarizing and adapting the Patient to transcutaneous electrical stimulation. Stimulation during Step 1 will be delivered using a CE approved TensMed S82 device. Following the conditioning stimulation, the Patient will undergo Step 2: incrementally increasing perineal stimulation, in order to identify the electrical intensity of his sensory and motor activation. The Patient will recognize motor activation as a muscle contraction, similarly to the voluntary induced muscle contraction when delaying urination. Step 2 will be repeated twice. Finally, the Patient will undergo Step 3: 10 to 15 minutes (according to Investigator's discretion) of continuous functional intensity stimulation, delivered to the Patient's perineum, aiming at demonstrating safety of prolonged stimulation. Stimulation during Steps 2 and 3 will be delivered using the investigational BLE (Bluetooth Low Energy)-enabled vPatch device. Furthermore, the Investigator will carefully instruct the Patient how to safely place the device, how to safely use of the device, and how to remove the device. During this visit the baseline assessments (see flow chart) will be carried out.

Following the Visit 2, the Home Phase will initiate, where the Patients will be asked to have 4 sexual intercourse sessions with their female partners, in the privacy of their home, during which their partner will measure their Intravaginal Ejaculatory Latency Time (IELT) using a stopwatch. The 4 sessions will include four IELT measurements, while the investigational BLE-disabled vPatch device is applied, pre-configured either delivering a functional stimulation to 40 Patients (Active Device Group) or sensory stimulation to 20 Patients (Sham Device Group). All Patients will be informed that the stimulation is not necessarily detectable. The Investigator will call the Patients every day during the first three days of the Home Phase to monitor the progression and to remind to fill in the 72 h Safety Questionnaire.

The Patients will be requested to return to the site (Visit 3) after 4 intercourse sessions with their female partners in order to undergo the assessments foreseen by protocol (see flow chart) and to return the filled questionnaires and the used device. This will be considered the End of Trial Visit.

Inclusion criteria

• Male Patients, aged ≥ 18 and ≤ 60 years old.
• Patients who are diagnosed with clinical premature ejaculation or with self-perceived ELT < 3 minutes.
• Patients with stable, heterosexual, monogamous, sexual relationship for at least 3 months at the time of the enrolment.
• Patients planning to maintain the relationship for the whole duration of the study.
• Patients with 75% of IELT baseline measurement < 2 minutes and 25% of IELT baseline measurement < 3 minutes at Visit 2.
• Patients with PEDT (Premature Ejaculation Diagnostic Tool) measurement ≥ 11 at the time of enrolment.
• Patients with IIEF-5 (International Index of Erectile Function) measurement ≥ 22 at the time of enrolment.
• Patients understanding the nature of the study and providing their informed consent to participation.
• Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.

Exclusion criteria

• Patients with history of cardiovascular disorders.
• Patients with history of other sexual dysfunction (other than PE).
• Patients suffering of erectile dysfunction.
• Patients carrying any type of implanted pacemaker/defibrillator.
• Patients suffering of diagnosed Diabetes Mellitus with peripheral neuropathy.
• Patients suffering of perineal dermatological diseases.
• Patients suffering of perineal skin irritation / lesions.
• Patients suffering of any psychiatric major disease (axis 1) and/or taking any relevant medications.
• Patients taking antidepressant therapy, topical anesthetic agents or sexual-related cognitive behavioral therapy within the 4 weeks before the enrolment.
• Patients with past occurrences of ejaculation before intromission.
• Patients with history of genital or anorectal neoplastic illness in the 2 years before the enrolment.
• Patients with pregnant partner.
• Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
• Patients with any medical incidence where the use of the device may jeopardize the Patient's safety per Investigator's discretion.