NCT03150758

Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatectomy

Interventions

Type	Name	Description
DEVICE	10Hz + 100 micro-seconds	10Hz Electrical Stimulation with a pulse width of 100 micro-seconds
DEVICE	10Hz + 200 micro-seconds	10Hz Electrical Stimulation with a pulse width of 200 micro-seconds
DEVICE	7Hz + 100 micro-seconds	7Hz Electrical Stimulation with a pulse width of 100 micro-seconds
DEVICE	7Hz + 200 micro-seconds	7Hz Electrical Stimulation with a pulse width of 200 micro-seconds

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-04-24
• Completion: 2018-04-24
• First posted: 2017-05-12
• Last updated: 2020-02-12
• Results posted: 2020-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study