Erectile Dysfunction Following Radical ProstatectomyNCT06968494
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
A study testing Activation of pro-erectile nerves within the pelvic plexus in people with Erectile Dysfunction Following Radical Prostatectomy, run by Comphya Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Activation of pro-erectile nerves within the pelvic plexus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Rana Harb, 410-502-5500, rharb1@jhmi.edu
Christian Pavlovich, MD
About this study
Official title: Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
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:
Read more
- 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.
- Being tested
- Activation of pro-erectile nerves within the pelvic plexus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation of pro-erectile nerves within the pelvic plexusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implanted group | Experimental | Participants in the implanted group will be implanted with the study device during ongoing prostatectomy surgery. Receives: Device: Activation of pro-erectile nerves within the pelvic plexus |
| Control group | No intervention | Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Adverse events will be systematically reported.
Measured: 6 months
Occurrence of surgical complications
Surgical complications will be ranked according to the Clavien-Dindo classification
Measured: 6 months
Occurrence of device deficiencies
Device deficiencies will be systematically reported and recorded.
Measured: 6 months
Pain assessment
Participants will be asked to rate pain on a visual analog scale (from 0 to 10)
Measured: 6 months
Secondary outcomes (4)
Device Effectiveness
Device effectiveness will be assessed by asking participants to complete validated questionnaires.
Measured: 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.
Measured: 6 months
Duration of Surgical Implantation Procedure
Time (in minutes) from initial implant placement to final suture of the implant.
Measured: During surgical procedure
Ease of Implantation Steps
Surgeon-reported rating of the ease of each implantation step using a standardized ordinal scale.
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start5 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comphya Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Pavlovich, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968494
- Sponsor's protocol ID
- CP-1.103
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes