Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03150758
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatectomy	Device: 10Hz + 100 micro-seconds; Device: 10Hz + 200 micro-seconds; Device: 7Hz + 100 micro-seconds; Device: 7Hz + 200 micro-seconds	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Apr 24, 2018
• Actual Study Completion Date: Apr 24, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Electrical Stimulation 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-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

Outcome Measures

Primary Outcome Measures

1. Maximum Cavernosal Nerve Stimulation Threshold [Up to 21 days after prostatectomy]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Eric Klein, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 29, 2016
• Informed Consent Form - Jun 1, 2018

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT03150758
• Other Study ID Numbers: CASE1816
• First Posted: May 12, 2017
• Last Update Posted: Feb 12, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Case Comprehensive Cancer Center: Erectile Disfunction; Urinary Function

Study Results

Participant Flow

Arm/Group Title	Electrical Stimulation
Arm/Group Description	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 10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds 10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds 7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds 7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Electrical Stimulation
Arm/Group Description	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 10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds 10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds 7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds 7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds
Overall Participants	6
Age, Customized (participants) [Number]
20-29 years	0 0%
30-39 years	0 0%
40-49 years	0 0%
50-59 years	6 100%
60-69 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	6 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	6 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Cavernosal Nerve Stimulation Threshold
Description	Median value of "maximum stimulation pattern men received prior to erection" in responders
Time Frame	Up to 21 days after prostatectomy

Outcome Measure Data

Analysis Population Description

Participants who responded to therapy

Arm/Group Title	Electrical Stimulation
Arm/Group Description	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 10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds 10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds 7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds 7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds
Measure Participants	6
Median (Inter-Quartile Range) [mA]	7.5

Adverse Events

Time Frame	up to 30 days from end of treatment
Arm/Group Title	Electrical Stimulation
Arm/Group Description	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 10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds 10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds 7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds 7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds
All Cause Mortality
	Electrical Stimulation
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Electrical Stimulation
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Electrical Stimulation
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.