Trial Outcomes & Findings for A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function (NCT NCT02006927)

NCT ID: NCT02006927

Last Updated: 2020-10-22

Results Overview

Evaluate the safety and tolerability of chronic cavernous nerve stimulation post radical prostatectomy by measuring the incidence of major complications that may include lead removal, infection at the site or painful stimulation requiring lead removal.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Nerve Stimulation Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Nerve Stimulation Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nerve Stimulation n=3 Participants Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	59.3 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	2 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	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All participants withdrawn from study prior to any data collection or analysis. No data analyzed to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: All participants withdrawn from study prior to any data collection or analysis. No data analyzed to report.

Explore the potential efficacy of chronic cavernous nerve stimulation on the return of erectile function post radical prostatectomy. Measures to assess efficacy include direct response to stimulation, changes in penile tumescence (girth) and sensory perception.

Outcome measures

Outcome data not reported

Adverse Events

Nerve Stimulation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nerve Stimulation n=3 participants at risk Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
Gastrointestinal disorders Nausea/vomiting	33.3% 1/3 • Number of events 1 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.
Reproductive system and breast disorders Device lead migration	100.0% 3/3 • Number of events 3 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.
Renal and urinary disorders Hematuria	66.7% 2/3 • Number of events 2 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.
Reproductive system and breast disorders Infected pelvic hematoma	66.7% 2/3 • Number of events 2 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	33.3% 1/3 • Number of events 1 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.
Renal and urinary disorders Bladder leak	33.3% 1/3 • Number of events 1 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.
Gastrointestinal disorders Hiatal hernia	33.3% 1/3 • Number of events 1 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.
Gastrointestinal disorders Gastric ulcer	33.3% 1/3 • Number of events 1 • 24 months Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.

Additional Information

Deborah Hasenau, RN

William Beaumont Hospitals

Phone: 248 551-0804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place