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Investigating a New Implantable Device for Erectile Dysfunction After Prostatectomy

This study is testing a new implantable device designed to treat erectile dysfunction (ED) in men who have had a radical prostatectomy (surgery to remove the prostate gland). The device works by sending electrical pulses to the nerves that help with erections. Researchers want to see if this device is safe and if it helps men recover natural erectile function. You might be eligible if you are a man between 30 and 75 years old, have certain stages of prostate cancer, and meet specific criteria for erectile function. The study will look at how often side effects, surgical problems, or device issues occur over 6 months. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This interventional study aims to enroll 20 participants. Researchers will compare a group with the device to a group without the device.
What's involved
If you participate, the device will be implanted during your prostatectomy surgery. You will have follow-up visits, complete questionnaires, activate the device daily, and measure erection hardness for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to monitor for adverse events, surgical complications, and device deficiencies.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06968494

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

Recruiting
NAAges 30–75InterventionalTreatment
Comphya Inc.
~20 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Activation of pro-erectile nerves within the pelvic plexus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of adverse events
Measured over 6 months
+3 more outcomes measured

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Christian Pavlovich, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Rana Harb
[email protected]
410-502-5500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Occurrence of adverse events6 months

    Adverse events will be systematically reported.

  • Occurrence of surgical complications6 months

    Surgical complications will be ranked according to the Clavien-Dindo classification

  • Occurrence of device deficiencies6 months

    Device deficiencies will be systematically reported and recorded.

  • Pain assessment6 months

    Participants will be asked to rate pain on a visual analog scale (from 0 to 10)