Implantable device to treat erectile dysfunction after radical prostatectomy

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy

This trial will test whether a new implantable device can safely improve erections in men who develop erectile dysfunction after nerve-sparing radical prostatectomy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 30 Years to 75 Years
• Sex: Male
• Sponsor: Comphya Inc. (Industry-sponsored)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06968494 on ClinicalTrials.gov

What this trial studies

Participants undergoing nerve-sparing radical prostatectomy will receive the implantable device during their surgery or be compared with a control group who do not receive the device. The device is designed to activate pro-erectile nerves within the pelvic plexus, and implanted participants will be asked to activate it daily and measure erection hardness. All participants will attend scheduled follow-up visits and complete questionnaires over six months to monitor safety, device function, and satisfaction. Outcomes in the implanted group will be compared with the control group, with safety as the primary focus and erectile function and patient-reported satisfaction as secondary measures.

Who should consider this trial

Good fit: Men aged 30–75 scheduled for nerve-sparing radical prostatectomy for localized prostate cancer (T1c–T2a, limited low-volume Grade Group 3 allowed) with strong preoperative erectile function (IIEF-15 erectile function domain ≥26) and willingness to have the device implanted and attend follow-up visits are the intended candidates.

Not a fit: Men with neurological disease, prior pelvic surgery or radiation, significant preoperative erectile dysfunction (IIEF-15 <26), history of priapism or Peyronie disease, or very high PSA (>20 ng/mL) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the device could preserve or improve erectile function after prostatectomy and reduce the need for later invasive treatments.

How similar studies have performed: Pelvic nerve stimulation for post-prostatectomy erectile dysfunction is a relatively novel approach with limited human data, so similar implant-based methods remain largely unproven to date.

Eligibility criteria

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).

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Christian Pavlovich, MD — Johns Hopkins University
• Study coordinator: Rana Harb

Conditions Erectile Dysfunction Following Radical Prostatectomy