Actively Recruiting
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
Led by Comphya Australia · Updated on 2026-03-18
20
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is focused on men experiencing erectile dysfunction after radical prostatectomy, a surgery for localized prostate cancer. Researchers aim to evaluate the safety and performance of a new implantable device designed to help with erectile function recovery. The study compares men receiving the device during nerve-sparing prostatectomy with those undergoing standard surgery without the device. The investigational device is implanted during the prostatectomy surgery and works by delivering electrical pulses to activate the pro-erectile nerves in the pelvic plexus. Participants with the device are asked to activate it daily to potentially aid in restoring natural erectile function. The control group receives the standard nerve-sparing prostatectomy without device implantation. Participants will be followed for 6 months after surgery, attending hospital visits and completing questionnaires. They will activate the device daily if implanted and measure erection hardness. Researchers will monitor adverse events, surgical complications, device performance, pain levels, and erectile function recovery. This follow-up period helps assess both safety and effectiveness of the device.
CONDITIONS
Brief Title
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men between 30 and 70 years old
- Men scheduled for nerve-sparing prostatectomy surgery
- Localized prostate cancer suitable for bilateral nerve-sparing prostatectomy
- International Index of Erectile Function (IIEF-15) erectile function score of 26 or higher before prostatectomy
- Interest in minimizing erectile dysfunction after surgery
- Ability to understand study information and provide written consent
You will not qualify if you...
- Neurological diseases or history of spinal cord injury or trauma
- IIEF-15 erectile function score less than 26 before prostatectomy
- Inadequate nocturnal erectile function before prostatectomy
- History of erectile dysfunction, priapism, or Peyronie disease
- Previous pelvic surgery, trauma, or radiation therapy
- Presence of an active implantable device
- Neurologic degenerative diseases affecting erectile function
- Limitations preventing nerve-sparing techniques during surgery
- Inability to understand or use the device
- Insulin-dependent diabetes with peripheral neuropathy or complications
- Unwillingness to engage in sexual activity
- Participation in another conflicting clinical trial
- Participation in any drug or device trial within the last 4 weeks or planned in next 24 months
- Any other conditions increasing risk or impairing data collection as judged by investigator
- Membership in a vulnerable population lacking consent capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo nerve-sparing prostatectomy surgery. For those in the implanted group, the study device is implanted during the surgery.
1 surgical visit and immediate post-operative monitoring
Duration - Up to 6 months
Participants in the implanted group activate the device daily to stimulate the nerves and aid recovery of erectile function. Participants in the control group receive standard care without the device.
Regular follow-up visits during treatment as per study schedule
Duration - Up to 6 months post-surgery
Participants are monitored for safety outcomes including adverse events, surgical complications, device deficiencies, and pain.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 4 locations
1
St. Vincent's Private Hospital
Fitzroy, Victoria, Australia, 3065
Active, Not Recruiting
2
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Active, Not Recruiting
3
Australian Prostate Centre
North Melbourne, Victoria, Australia, 3051
Actively Recruiting
4
Epworth HealthCare
Richmond, Victoria, Australia, 3121
Active, Not Recruiting
Research Team
H
Helen Crowe
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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