Evaluation of the Safety and Effectiveness of the vPatch Device

NACompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

September 10, 2019

Primary Completion Date

July 15, 2020

Study Completion Date

July 16, 2020

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.

Trial Locations (3)

50019

"Urologia, Casa di Cura Villa Donatello", Sesto Fiorentino

80131

"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", Napoli

3109601

Sexual Dysfunction Clinic, Rambam Medical Center, Haifa

All Listed Sponsors
collaborator

Sintesi Research Srl

INDUSTRY

lead

Virility Medical Ltd.

INDUSTRY

NCT03942367 - Evaluation of the Safety and Effectiveness of the vPatch Device | Biotech Hunter | Biotech Hunter