The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The study device is an active implantable device. The device activates the pro-erectile nerves by delivering electrical pulses. The daily delivery of electrical pulses to the pro-erectile nerves may allow participants to recover natural erectile function.
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGOccurrence of adverse events
Adverse events will be systematically reported.
Time frame: 6 months
Occurrence of surgical complications
Surgical complications will be ranked according to the Clavien-Dindo classification
Time frame: 6 months
Occurrence of device deficiencies
Device deficiencies will be systematically reported and recorded.
Time frame: 6 months
Pain assessment
Participants will be asked to rate pain on a visual analog scale (from 0 to 10)
Time frame: 6 months
Device Effectiveness
Device effectiveness will be assessed by asking participants to complete validated questionnaires.
Time frame: 6 months
Erectile function rehabilitation
Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of rehabilitation of natural erectile function.
Time frame: 6 months
Duration of Surgical Implantation Procedure
Time (in minutes) from initial implant placement to final suture of the implant.
Time frame: During surgical procedure
Ease of Implantation Steps
Surgeon-reported rating of the ease of each implantation step using a standardized ordinal scale.
Time frame: During surgical procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.