N/A
N=6
Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold
Prostatectomy
Bottom Line
View on ClinicalTrials.gov: NCT03150758 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Maximum Cavernosal Nerve Stimulation Threshold — 7.5 mA
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 10Hz + 100 micro-seconds (Device); 10Hz + 200 micro-seconds (Device); 7Hz + 100 micro-seconds (Device); 7Hz + 200 micro-seconds (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Cavernosal Nerve Stimulation Threshold |
7.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03150758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.