Erectile Dysfunction Following Radical ProstatectomyNCT05650866
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 Australia at 4 sites in Australia.
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 70 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
- 4 sitesAustralia
- Study dates
- 19 May 2023to 30 Jun 2028
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men of ages between 30-70 years;
- Men with indication for nerve-sparing prostatectomy surgery;
- Localised prostate cancer considered suitable for bilateral nerve sparing prostatectomy according to clinical criteria
- International Index of Erectile Function (IIEF-15) erectile function domain score equal to or greater than 26 prior prostatectomy;
- 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 prior prostatectomy;
- Failure to demonstrate adequate nocturnal erectile function prior prostatectomy;
- History of erectile dysfunction, priapism and Peyronie disease;
- History of previous pelvic surgery, trauma or irradiation therapy;
- Currently have an active implantable device;
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- 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
4 sites in 1 country.
Australia4 sites
St. Vincent's Private Hospital
Fitzroy, Victoria, 3065
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Australian Prostate Centre
North Melbourne, Victoria, 3051
Epworth HealthCare
Richmond, Victoria, 3121
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 cavernous nerves by delivering electrical pulses, to trigger an on-demand erection. The daily delivery of electrical pulses to the cavernous nerves will also allow participants to recover natural erectile function.
| Study group | Role | What they receive |
|---|---|---|
| Implanted group | Experimental | The study device will be implanted during the ongoing prostatectomy surgery. Participants will then be asked to activate it everyday. 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 reported using MedDRA terminology.
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
Patients will be asked to rate pain on a visual analog scale (from 0 to 10)
Measured: 6 months
Secondary outcomes (4)
Objective Device effectiveness
Erectile response obtained when activating the study device will be objectively assessed by measuring penile rigidity with the RigiScan device.
Measured: 6 months
Subjective Device effectiveness
Erectile function will be subjectively assessed by asking participants to complete validated questionnaires (International Index of Erectile Function, IIEF-15 and Erection Hardness Score, EHS).
Measured: 6 months
Erectile function recovery
Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of recovery of natural erectile function.
Measured: 6 months
Delineation of the surgical implantation procedure
The surgeon will record information related to the implantation (duration, position of the device, grading ease of implantation steps, and any comments).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start19 May 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (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 Australia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650866
- Sponsor's protocol ID
- CP-1.5400
- Status last verified
- Sep 2026
- First submitted
- 28 Nov 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No