NCT05650866 Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
| NCT ID | NCT05650866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Comphya Australia |
| Condition | Erectile Dysfunction Following Radical Prostatectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-05-19 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05650866 clinical trial?
This trial is open to male participants only, aged 30 Years or older, up to 70 Years, studying Erectile Dysfunction Following Radical Prostatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05650866 currently recruiting?
Yes, NCT05650866 is actively recruiting participants. Contact the research team at helenrcrowe@gmail.com for enrollment information.
Where is the NCT05650866 trial being conducted?
This trial is being conducted at Fitzroy, Australia, Melbourne, Australia, North Melbourne, Australia, Richmond, Australia.
Who is sponsoring the NCT05650866 clinical trial?
NCT05650866 is sponsored by Comphya Australia. The trial plans to enroll 20 participants.