NCT02006927

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Kenneth M Peters, MD · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate electrical stimulation of nerves responsible for erectile function after surgery to remove the prostate (prostatectomy). Electrical stimulation of the nerves responsible for erectile function is experimental. The investigators hypothesize that the subjects can tolerate nerve stimulation.

Detailed description

The objective of the study is to explore the feasibility of using an implantable neurostimulation device/leads post radical robotic prostatectomy as a method for enhancing neural recovery/penile rehabilitation and/or erectile dysfunction treatment. This will be a single center pilot study of up to 10 patients. The leads will be placed and stimulated intraoperatively to assess proper placement and stimulation parameters needed to achieve change in penile length and/or circumference. One week post operatively, the leads will be connected to an external stimulator device and activated. Subjects will be instructed to stimulate each lead by turning on the device each day for up to six weeks. The leads will be removed at six weeks post operative and subjects will be followed for up to two years.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Nerve Stimulation	Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-05-01
• Completion: 2017-04-01
• First posted: 2013-12-10
• Last updated: 2020-10-22
• Results posted: 2020-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study