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

Recruiting now · Not applicable

Conditions studied: Erectile Dysfunction Following Radical Prostatectomy

In brief

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.

Key facts

Study ID

NCT05650866

Run by

Comphya Australia

People needed

20

Starts

2023-05-19

Expected to finish

2026-08-31

Last updated by the study team

2026-03-18

Who can join

Age: 30 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Australian Prostate Centre — North Melbourne, Victoria, Australia (enrolling)
• St. Vincent's Private Hospital — Fitzroy, Victoria, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• Epworth HealthCare — Richmond, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.