Actively Recruiting
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Led by Comphya Australia · Updated on 2026-03-18
20
Participants Needed
4
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 aged between 30 and 70 years
- Candidates 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
- Interested in minimizing erectile dysfunction effects after prostatectomy
- Able to read, understand patient information, and provide informed consent
You will not qualify if you...
- Neurological diseases including 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
- Technical or clinical limitations preventing nerve-sparing surgery
- Inability to understand or use the study device
- Insulin-dependent diabetes with peripheral neuropathy or related complications
- Unwillingness to engage in sexual activity
- Participation in another clinical trial contraindicating neurostimulator implantation
- Participation in any drug or device trial within the last 4 weeks or planned participation within 24 months
- Any other condition 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
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
CONTACT
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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