Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
Overview
- Phase
- N/A
- Intervention
- Activation of pro-erectile nerves within the pelvic plexus
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy
- Sponsor
- Comphya Australia
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Occurrence of adverse events
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
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;
Arms & Interventions
Implanted group
The study device will be implanted during the ongoing prostatectomy surgery. Participants will then be asked to activate it everyday.
Intervention: Activation of pro-erectile nerves within the pelvic plexus
Control group
Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device.
Outcomes
Primary Outcomes
Occurrence of adverse events
Time Frame: 6 months
Adverse events will be reported using MedDRA terminology.
Occurrence of surgical complications
Time Frame: 6 months
Surgical complications will be ranked according to the Clavien-Dindo classification
Pain
Time Frame: 6 months
Patients will be asked to rate pain on a visual analog scale (from 0 to 10)
Occurrence of device deficiencies
Time Frame: 6 months
Device deficiencies will be systematically reported and recorded.
Secondary Outcomes
- Delineation of the surgical implantation procedure(6 months)
- Objective Device effectiveness(6 months)
- Subjective Device effectiveness(6 months)
- Erectile function recovery(6 months)