NCT03150758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

May 10, 2017

Results QC Date

January 28, 2020

Last Update Submit

February 11, 2020

Conditions

Prostatectomy

Keywords

Erectile DisfunctionUrinary Function

Outcome Measures

Primary Outcomes (1)

  • Maximum Cavernosal Nerve Stimulation Threshold

    Median value of "maximum stimulation pattern men received prior to erection" in responders

    Up to 21 days after prostatectomy

Study Arms (1)

Electrical Stimulation

EXPERIMENTAL

Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded

Device: 10Hz + 100 micro-secondsDevice: 10Hz + 200 micro-secondsDevice: 7Hz + 100 micro-secondsDevice: 7Hz + 200 micro-seconds

Interventions

10Hz + 100 micro-secondsDEVICE

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

Electrical Stimulation
10Hz + 200 micro-secondsDEVICE

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

Electrical Stimulation
7Hz + 100 micro-secondsDEVICE

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

Electrical Stimulation
7Hz + 200 micro-secondsDEVICE

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

Electrical Stimulation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

Title
Dr. Eric Klein
Organization
Cleveland Clinic
CancerCenterResearch@ccf.org
1-800-223-2273

Study Officials

  • Eric Klein, MD

    Cleveland Clinic, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 12, 2017

Study Start

January 1, 2017

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

February 12, 2020

Results First Posted

February 12, 2020

Record last verified: 2020-02

Locations

US(1)