Prostatectomy
Conditions
Keywords
Erectile Disfunction, Urinary Function
Brief summary
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.
Detailed description
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.
Interventions
DEVICE10Hz + 100 micro-seconds
10Hz Electrical Stimulation with a pulse width of 100 micro-seconds
DEVICE10Hz + 200 micro-seconds
10Hz Electrical Stimulation with a pulse width of 200 micro-seconds
DEVICE7Hz + 100 micro-seconds
7Hz Electrical Stimulation with a pulse width of 100 micro-seconds
DEVICE7Hz + 200 micro-seconds
7Hz Electrical Stimulation with a pulse width of 200 micro-seconds
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have prostate cancer being treated via radical prostatectomy by a single surgeon (primary investigator) with planned intraoperative nerve sparing. * Subjects must have intact preoperative erectile function, sufficient for penetrative intercourse without medication nor assistive device, as defined by a Sexual Health Inventory for Men (SHIM) / International Index of Erectile Function (IIEF-2) score 22 or higher, which is collected as part of routine care. * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a SHIM / IIEF-2 21 or lower, which is collected as part of routine care. * Lack of successful intraoperative nerve sparing. * Neurologic, metabolic, or vascular diseases that may negatively impact erectile function, such as: diabetes mellitus, peripheral vascular disease, coronary artery disease, stroke, multiple sclerosis, parkinson's disease, multiple systems atrophy, epilepsy, or spinal cord injury. * Inability to provide a fully informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Cavernosal Nerve Stimulation Threshold | Up to 21 days after prostatectomy | Median value of maximum stimulation pattern men received prior to erection in responders |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Electrical Stimulation |
|---|---|
| Age, Customized 20-29 years | 0 participants |
| Age, Customized 30-39 years | 0 participants |
| Age, Customized 40-49 years | 0 participants |
| Age, Customized 50-59 years | 6 participants |
| Age, Customized 60-69 years | 0 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Maximum Cavernosal Nerve Stimulation Threshold
Median value of maximum stimulation pattern men received prior to erection in responders
Time frame: Up to 21 days after prostatectomy
Population: Participants who responded to therapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electrical Stimulation | Maximum Cavernosal Nerve Stimulation Threshold | 7.5 mA |