CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
10Hz + 100 micro-seconds +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03150758
NCT03150758N/ACompleted

Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold

Case Comprehensive Cancer Center·interventional·Posted May 12, 2017·Updated Feb 12, 2020

In Brief

A clinical study evaluating 10Hz + 100 micro-seconds, 10Hz + 200 micro-seconds, and 2 other interventions for Prostatectomy. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatectomy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartJan 1, 2017
Primary CompletionApr 24, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.1 years ago

Interventions

10Hz + 100 micro-secondsdevice

10Hz Electrical Stimulation with a pulse width of 100 micro-seconds

10Hz + 200 micro-secondsdevice

10Hz Electrical Stimulation with a pulse width of 200 micro-seconds

7Hz + 100 micro-secondsdevice

7Hz Electrical Stimulation with a pulse width of 100 micro-seconds

7Hz + 200 micro-secondsdevice

7Hz Electrical Stimulation with a pulse width of 200 micro-seconds