Trial Outcomes & Findings for Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold (NCT NCT03150758)

NCT ID: NCT03150758

Last Updated: 2020-02-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Up to 21 days after prostatectomy

Results posted on

2020-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	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 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 Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrical Stimulation n=6 Participants 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
Age, Customized 20-29 years	0 participants n=5 Participants
Age, Customized 30-39 years	0 participants n=5 Participants
Age, Customized 40-49 years	0 participants n=5 Participants
Age, Customized 50-59 years	6 participants n=5 Participants
Age, Customized 60-69 years	0 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 21 days after prostatectomy

Population: Participants who responded to therapy

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

Outcome measures

Outcome measures
Measure	Electrical Stimulation n=6 Participants 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
Maximum Cavernosal Nerve Stimulation Threshold	7.5 mA Interval 5.0 to 11.25

Adverse Events

Electrical Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Klein

Cleveland Clinic

Phone: 1-800-223-2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place