Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-07-06 @ 1:42 AM
Study NCT ID:
NCT03150758
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: