Evaluation of the Safety and Effectiveness of the vPatch Device

NCT03942367 | Completed

• 1 other identifier: CL-PR-03-01
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Premature Ejaculation; Sexual Medicine; Urology; Sexual Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Evaluation of Patient's subjective outcome assessment of the Premature Ejaculation Profile (PEP) from baseline (V2) to the end of Home Phase Visit (V3).

  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).

  Up to 56 days

• Evaluation of Patient's subjective outcome assessment of ease of use of the vPatch device and treatment during Home Phase.

  Entire Study Period (up to 2,5 months)

Study Arms (2)

Group A (Active Device Group)

EXPERIMENTAL

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)

Group B (Sham Device Group)

SHAM COMPARATOR

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)

Interventions

Active Device (vPatch) DEVICE

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

Group A (Active Device Group)

Sham Device (vPatch) DEVICE

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

Group B (Sham Device Group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Male Patients, aged ≥ 18 and ≤ 60 years old.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virility Medical Ltd.: lead
• Sintesi Research Srl: collaborator

Study Sites (3)

Sexual Dysfunction Clinic, Rambam Medical Center

Haifa, 3109601, Israel

Location

Urologia, Casa di Cura "Villa Donatello"

Sesto Fiorentino, Firenze, 50019, Italy

Location

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, 80131, Italy

Location

Related Publications (9)

• Giuliano F, Patrick DL, Porst H, La Pera G, Kokoszka A, Merchant S, Rothman M, Gagnon DD, Polverejan E; 3004 Study Group. Premature ejaculation: results from a five-country European observational study. Eur Urol. 2008 May;53(5):1048-57. doi: 10.1016/j.eururo.2007.10.015. Epub 2007 Oct 16.

  PMID: 17950985 BACKGROUND

• Tang WS, Khoo EM. Prevalence and correlates of premature ejaculation in a primary care setting: a preliminary cross-sectional study. J Sex Med. 2011 Jul;8(7):2071-8. doi: 10.1111/j.1743-6109.2011.02280.x. Epub 2011 Apr 14.

  PMID: 21492404 BACKGROUND

• Althof SE. Prevalence, characteristics and implications of premature ejaculation/rapid ejaculation. J Urol. 2006 Mar;175(3 Pt 1):842-8. doi: 10.1016/S0022-5347(05)00341-1.

  PMID: 16469562 BACKGROUND

• Shafik A. The mechanism of ejaculation: the glans-vasal and urethromuscular reflexes. Arch Androl. 1998 Sep-Oct;41(2):71-8. doi: 10.3109/01485019808987948.

  PMID: 9730435 BACKGROUND

• Dinsmore WW, Hackett G, Goldmeier D, Waldinger M, Dean J, Wright P, Callander M, Wylie K, Novak C, Keywood C, Heath P, Wyllie M. Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation. BJU Int. 2007 Feb;99(2):369-75. doi: 10.1111/j.1464-410X.2006.06583.x. Epub 2006 Nov 24.

  PMID: 17129234 BACKGROUND

• Patrick DL, Giuliano F, Ho KF, Gagnon DD, McNulty P, Rothman M. The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice. BJU Int. 2009 Feb;103(3):358-64. doi: 10.1111/j.1464-410X.2008.08041.x. Epub 2008 Sep 12.

  PMID: 18793300 BACKGROUND

• Althof SE, Brock GB, Rosen RC, Rowland DL, Aquilina JW, Rothman M, Tesfaye F, Bull S. Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation. J Sex Med. 2010 Jun;7(6):2243-2252. doi: 10.1111/j.1743-6109.2010.01793.x. Epub 2010 Mar 30.

  PMID: 20367770 BACKGROUND

• Limoncin E, Lotti F, Rossi M, Maseroli E, Gravina GL, Ciocca G, Mollaioli D, Di Sante S, Maggi M, Lenzi A, Jannini EA. The impact of premature ejaculation on the subjective perception of orgasmic intensity: validation and standardisation of the 'Orgasmometer'. Andrology. 2016 Sep;4(5):921-6. doi: 10.1111/andr.12220. Epub 2016 May 23.

  PMID: 27214119 BACKGROUND

• Shechter A, Mondaini N, Serefoglu EC, Gollan T, Deutsch F, Appel B, Gruenwald I. A novel on-demand therapy for lifelong premature ejaculation using a miniature transperineal electrical stimulator-the vPatch: an as-treated analysis. J Sex Med. 2023 Jan 14;20(1):22-29. doi: 10.1093/jsxmed/qdac012.

  PMID: 36897239 DERIVED

Related Links

• Virility Medical Ltd. official website

MeSH Terms

Conditions

Premature Ejaculation; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Ilan Gruenwald, MD

  Sexual Dysfunction Clinic, Rambam Medical Center - Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: An unblinded sub-Investigator will preconfigure the patches to be active or sham, and pack them in 4 patches per box. The randomization will be carried out in accordance to the the instructions provided, keeping the Investigator's and Patient's blindness about the configuration of each patch.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 8, 2019
• Study Start: September 10, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 16, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); IT (2)