Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional TENS stimulation | Experimental | Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation] |
|
| Non-stimulation treatment | Sham Comparator | Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional TENS stimulation | Device | A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm' |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint) | Procedure day |
| Change in ejaculation latency time | The difference between patient ejaculation latency time under perineal functional electrical stimulation during self-stimulation, and latency time during self-stimulation while no electrical stimulation is applied | Procedure day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-treatment Adverse Events | Post treatment safety evaluation completed by subjects (using safety questionnaire) | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire | Self reported - user questionnaire | Procedure day |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Gruenwald, MD | Contact | +972-4-777-2819 |
| Name | Affiliation | Role |
|---|---|---|
| Ilan Gruenwald, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Recruiting | Haifa | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 7, 2019 | |
| Reset | Oct 30, 2019 | |
| Release | Nov 27, 2019 | |
| Reset | Dec 17, 2019 | |
| Release | Aug 9, 2021 | |
| Reset | Sep 3, 2021 | |
| Release | Nov 15, 2021 | |
| Reset | Jan 18, 2022 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 7, 2019 | Oct 30, 2019 | |||
| Nov 27, 2019 |
| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Non-Functional TENS stimulation | Device | A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm' |
|
| Dec 17, 2019 |
| Aug 9, 2021 | Sep 3, 2021 |
| Nov 15, 2021 | Jan 18, 2022 |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |