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Erectile dysfunction persists in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not provided benefit. Electrical stimulation has been demonstrated to benefit neuroregeneration and the functional recovery of neuromuscular systems. Therefore, electrical stimulation of the cavernosal nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy. This pilot study is intended to determine the threshold of electrical stimulation that results in penile erection, as defined by persistent intracavernosal pressure increase, such that future studies of sub-threshold stimulation may be pursued.
Objective:
To determine the cavernosal nerve electrical stimulation amplitude thresholds at which an erection, as indicated by persistent increases in intracavernosal pressure, occurs for various stimuli of fixed frequency and fixed pulse-width.
Study Design:
This is a prospective pilot study used to determine a threshold range of cavernosal nerve electrical stimulation parameters that result in penile erection. Assignment to the order of stimulation paradigms will be randomized. No placebos are used. No blinding is used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Stimulation | Experimental | Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10Hz + 100 micro-seconds | Device | 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Cavernosal Nerve Stimulation Threshold | Median value of "maximum stimulation pattern men received prior to erection" in responders | Up to 21 days after prostatectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Klein, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electrical Stimulation | Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded 10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds 10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds 7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds 7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who were put on study
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| ID | Title | Description |
|---|---|---|
| BG000 | Electrical Stimulation | Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded 10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds 10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds 7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds 7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Cavernosal Nerve Stimulation Threshold | Median value of "maximum stimulation pattern men received prior to erection" in responders | Participants who responded to therapy | Posted | Median | Inter-Quartile Range | mA | Up to 21 days after prostatectomy |
|
up to 30 days from end of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electrical Stimulation | Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded 10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds 10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds 7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds 7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Klein | Cleveland Clinic | 1-800-223-2273 | CancerCenterResearch@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2016 | Jan 15, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2018 | Feb 10, 2020 | ICF_001.pdf |
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| 10Hz + 200 micro-seconds | Device | 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds |
|
| 7Hz + 100 micro-seconds | Device | 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds |
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| 7Hz + 200 micro-seconds | Device | 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds |
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| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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