Evaluation of the Safety and Effectiveness of the vPatch Device
Premature Ejaculation
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature Ejaculation, Sexual Medicine, Urology, Sexual Dysfunction
Eligibility Criteria
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.
Sites / Locations
- Sexual Dysfunction Clinic, Rambam Medical Center
- Urologia, Casa di Cura "Villa Donatello"
- U.O.C. Urologia e Centro di litotrissia urinaria D.A.I. Nefrologia, urologia e chirurgia generale e dei trapianti di rene, anestesia e rianimazione, A.O.U. "Federico II" di Napoli
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Group A (Active Device Group)
Group B (Sham Device Group)
Patients will receive a fully functioning vPatch device, pre-configured to deliver stimulation intensity according to the subjective motor threshold intensity reported by the Patients. Pre-configured stimulation intensity cannot be changed by the Patient.
Patients will receive a vPatch device pre-configured to deliver the sensory electrical stimulation according to the subjective sensory threshold that is ineffective for muscle activation. Pre-configured stimulation intensity cannot be changed by the Patient.