Assessing a new implantable device for treating erectile dysfunction after prostate surgery

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

This study is testing a new implantable device to see if it can help men regain erectile function after prostate surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 30 Years to 70 Years
• Sex: Male
• Sponsor: Comphya Australia (industry)
• Locations: 4 sites (Fitzroy, Victoria and 3 other locations)
• Trial ID: NCT05650866 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of a novel implantable device designed to treat erectile dysfunction in men following radical prostatectomy. Participants will receive the device during their surgery and will be monitored over a six-month period through follow-up visits and questionnaires. The study aims to compare the outcomes of those with the device against a control group without it, focusing on device satisfaction and erection hardness. The trial includes men aged 30-70 who are candidates for nerve-sparing prostatectomy and have a baseline erectile function score of 26 or higher.

Who should consider this trial

Good fit: Ideal candidates are men aged 30-70 undergoing nerve-sparing prostatectomy for localized prostate cancer with a baseline erectile function score of 26 or higher.

Not a fit: Patients with a history of erectile dysfunction, neurological diseases, or inadequate nocturnal erections prior to surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve erectile function and quality of life for men after prostate surgery.

How similar studies have performed: While similar approaches have been explored, this specific device and its application in this context are novel and have not been extensively tested in prior studies.

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).

Where this trial is running

Fitzroy, Victoria and 3 other locations

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

Study contacts

• Study coordinator: Helen Crowe

Conditions: Erectile Dysfunction Following Radical Prostatectomy