Evaluation of the Safety and Effectiveness of the vPatch Device
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Active Device (vPatch); Sham Device (vPatch)
Intervention type(s): Device; Device
Intervention description(s): Electrical stimulation inducing motor response at the pelvic-floor muscles. Stimulation will be delivered by vPatch device configured to motor intensity.; Electrical stimulation inducing sensory response at the perineum.Stimulation will be delivered by vPatch device configured to sensory intensity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary purpose: Treatment
Keywords: Premature Ejaculation; Sexual Medicine; Urology; Sexual Dysfunction