Erectile Dysfunction Following Radical Prostatectomy
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Comphya Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery; * Cancer stage T1c and T2a; * Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion of GG3 disease; * IIEF-15 erectile function domain score equal to or greater than 26; * Men interested in minimizing the effect of radical prostatectomy on erectile function; * Ability to read and understand patient information materials and willingness to sign a written informed consent.
Exclusion criteria
* Men with neurological disease, including a history of spinal cord injury or trauma; * IIEF-15 erectile function domain score less than 26; * Failure to demonstrate adequate nocturne erectile function prioi prostatectomy (nocturnal RigiScan measure); * Men with PSA \> 20 ng/mL; * History of ED, priapism and Peyronie disease; * History of previous pelvic surgery, trauma or irradiation therapy; * Currently have an active implantable device. * Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions; * Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation; * Inability to understand and demonstrate device use instructions; * Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications; * Patient unwillingness to engage in sexual activity; * Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function; * Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months; * Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study; * Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | 6 months | Participants will be asked to rate pain on a visual analog scale (from 0 to 10) |
| Occurrence of adverse events | 6 months | Adverse events will be systematically reported. |
| Occurrence of surgical complications | 6 months | Surgical complications will be ranked according to the Clavien-Dindo classification |
| Occurrence of device deficiencies | 6 months | Device deficiencies will be systematically reported and recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Effectiveness | 6 months | Device effectiveness will be assessed by asking participants to complete validated questionnaires. |
| Erectile function rehabilitation | 6 months | Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of rehabilitation of natural erectile function. |
| Duration of Surgical Implantation Procedure | During surgical procedure | Time (in minutes) from initial implant placement to final suture of the implant. |
| Ease of Implantation Steps | During surgical procedure | Surgeon-reported rating of the ease of each implantation step using a standardized ordinal scale. |
Countries
United States
Contacts
Primary ContactRana Harb
Outcome results
None listed