Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold

Completed · Not applicable

Conditions studied: Prostatectomy

In brief

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.

Key facts

Study ID

NCT03150758

Run by

Case Comprehensive Cancer Center

People needed

6

Starts

2017-01-01

Expected to finish

2018-04-24

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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