NCT03942367

Evaluation of the Safety and Effectiveness of the vPatch Device

Completed NA Last updated 8 October 2020

What this trial tests

NA trial testing Active Device (vPatch) in Premature Ejaculation in 59 participants. Completed in 16 July 2020.

Timeline

10 September 2019

Primary endpoint
15 July 2020

16 July 2020

Quick facts

Lead sponsor	Virility Medical Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	59
Start date	10 September 2019
Primary completion	15 July 2020
Estimated completion	16 July 2020
Sites	3 locations across Italy, Israel

Drugs / interventions tested

• Active Device (vPatch)
• Sham Device (vPatch)

Conditions studied

• Premature Ejaculation — all drugs for Premature Ejaculation →

Sponsor

Virility Medical Ltd.

Who can join

Adults 18 to 60, male only, with Premature Ejaculation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A novel on-demand therapy for lifelong premature ejaculation using a miniature transperineal electrical stimulator-the vPatch: an as-treated analysis.
   Shechter A, Mondaini N, Serefoglu EC, Gollan T, et al · · 2023 · cited 8× · PMID 36897239 · DOI 10.1093/jsxmed/qdac012