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

Recruiting
30 - 70 years of age
Male
Phase N/A

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Overview

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.

Eligibility

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).

Study details

Erectile Dysfunction Following Radical Prostatectomy

NCT05650866

Comphya Australia

15 February 2024

Step 1 Get in touch with the nearest study center
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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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