Tiny implant could spark natural erections after prostate removal
NCT ID NCT06968494
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new implantable device that stimulates nerves to help men recover natural erections after prostate cancer surgery. Twenty men aged 30-75 will receive the device during their prostate removal and be followed for 6 months. The main goals are to check if the device is safe and if it helps restore erectile function compared to a control group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- implantable nerve-stimulating device
- What this could lead to
- If it works, this device could help men regain natural erectile function after prostate removal, reducing the need for pills or injections.
- What could go wrong
- This is a very early, small trial with only 20 participants. The device requires surgery to implant, and it may not work for everyone or could cause side effects like pain or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a simple stretching device save erectile function after prostate cancer surgery?
- Could Urine-Derived exosomes or ozone therapy restore erections after prostate cancer surgery?
- Could a placental wrap help men recover erections faster after prostate cancer surgery?
- Prostate Surgery's hidden toll: study probes lasting impact on Men's lives
- Hidden artery could be key to better sex life after prostate surgery