Evaluation of the Safety and Effectiveness of the vPatch Device

Study Overview
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Brief Summary
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Multi-center, international, prospective, randomized, double-blind, two-arms, sham-controlled, first-in-human clinical investigation. The Patients will be allocated to one of the following groups: Group A (Active 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. Group B (Sham Device Group): 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. The study will start with a Screening Visit (Visit 1), when potential Patients complaining of PE will be informed about the investigation and its objectives. If they agree to participate, after signing a valid Informed Consent Form they will undergo a full medical history and physical examination and will be selected according to eligibility criteria except IELT (which will be examined at the next visit). The primary objective of this study is to assess the safety profile of the vPatch device and its effectiveness in delaying ejaculation when used in Patients suffering of PE. The secondary objectives of this study are: To assess the Patient's perception of the ease of use of the vPatch device and treatment, through the use of a dedicated questionnaire (Usability Questionnaire). To assess the Patient's perception of the changes in his Premature Ejaculation Profile (PEP) under different aspects with the use of device, through the use of a dedicated questionnaire (Control and Distress Domains of the Premature Ejaculation Profile (PEP) Questionnaire). To assess the Patient's perceived intensity of orgasm by using the vPatch device, through the use of a validated tool (Orgasmometer).

Detailed Description
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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.

Official Title
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Evaluation of the Safety and Effectiveness of the vPatch Device for the Management and Treatment of Premature Ejaculation

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Device: Active Device (vPatch)
* Device: Sham Device (vPatch)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double-blind, multi-center clinical trial. Patients enrolled will be randomized in a 2:1 ratio to receive active vPatch device (Group A) or a Sham Device (Group B).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Active Device Group)<br>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. | Device: Active Device (vPatch)<br>* Electrical stimulation inducing motor response at the pelvic-floor muscles. Stimulation will be delivered by vPatch device configured to motor intensity.<br>|
| Sham Comparator: Group B (Sham Device Group)<br>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. | Device: Sham Device (vPatch)<br>* Electrical stimulation inducing sensory response at the perineum.Stimulation will be delivered by vPatch device configured to sensory intensity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events rate during the study period. All adverse occurrences (serious/non-serious or device-related/non device-related) will be recorded prospectively, categorized and evaluated for causality using defined criteria. | Primary Endpoint of Safety | Entire Study Period (up to 2,5 months) | 
| Objective: change in IELT from baseline (V2) to the end of Home Phase Visit (V3). | Primary Endpoint of Device Performance | Up to 56 days | 
| Subjective: proportion of patients reporting an improvement according to the Clinical Global Impression of Change (CGIC) measured at V3. | Primary Endpoint of Device Performance | Up to 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Patient's subjective outcome assessment of the Premature Ejaculation Profile (PEP) from baseline (V2) to the end of Home Phase Visit (V3). | Secondary Endpoint of Device Performance | Up to 56 days | 
| Evaluation of Patient's subjective outcome assessment of orgasmic intensity via Orgasmometer from baseline (V2) to the end of Home Phase Visit (V3). | Secondary Endpoint of Device Performance | Up to 56 days | 
| Evaluation of Patient's subjective outcome assessment of ease of use of the vPatch device and treatment during Home Phase. | Secondary Endpoint of Device Performance | Entire Study Period (up to 2,5 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Ejaculation, Sexual Medicine, Urology, Sexual Dysfunction