Evaluation of the Safety and Effectiveness of the vPatch Device

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).

Conditions

• Premature Ejaculation

Interventions

DEVICE

Active Device (vPatch)

Electrical stimulation inducing motor response at the pelvic-floor muscles. Stimulation will be delivered by vPatch device configured to motor intensity.

DEVICE

Sham Device (vPatch)

Electrical stimulation inducing sensory response at the perineum.Stimulation will be delivered by vPatch device configured to sensory intensity.

Sponsors & Collaborators

• Sintesi Research Srl

  collaborator INDUSTRY

• Virility Medical Ltd.

  lead INDUSTRY

Principal Investigators

• Ilan Gruenwald, MD · Sexual Dysfunction Clinic, Rambam Medical Center - Haifa, Israel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-10

Primary Completion

2020-07-15

Completion

2020-07-16

Countries

• Israel
• Italy

Study Locations