An interventional study of Active Device (vPatch) and Sham Device (vPatch) in Premature Ejaculation, sponsored by Virility Medical Ltd.. Completed at 3 sites in 2 countries. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Virility Medical Ltd. · Not applicable, Interventional, and Treatment
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:
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:
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 59 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Virility Medical Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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
Time frame: 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
Time frame: 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
Time frame: Up to 56 days
Evaluation of Patient's subjective outcome assessment of the Premature Ejaculation Profile (PEP) from baseline (V2) to the end of Home Phase Visit (V3).
Secondary Endpoint of Device Performance
Time frame: 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).
Secondary Endpoint of Device Performance
Time frame: Up to 56 days
Evaluation of Patient's subjective outcome assessment of ease of use of the vPatch device and treatment during Home Phase.
Secondary Endpoint of Device Performance
Time frame: Entire Study Period (up to 2,5 months)
Plan to share: No
Ran from Sep 2019 to primary completion in Jul 2020, 10 months.
Of 25 interventional studies with no phase under Premature Ejaculation, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 10 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Virility Medical Ltd.