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Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold

NCT03150758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-12

Study results available
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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.

Conditions

  • Prostatectomy

Interventions

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

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Eric Klein, MD · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-04-24
Completion
2018-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150758 on ClinicalTrials.gov