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Recruiting NCT05650866

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

No phase Interventional Erectile Dysfunction Following Radical Prostatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Activation of pro-erectile nerves within the pelvic plexus.
Who it may be relevant to
Registry conditions: Erectile Dysfunction Following Radical Prostatectomy. Basic parameters: 30 years — 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device Activation of pro-erectile nerves within the pelvic plexus
    The study device is an active implantable device. The device activates the cavernous nerves by delivering electrical pulses, to trigger an on-demand erection. The daily delivery of electrical pulses to the cavernous nerves will also allow participants to recover natural erectile function.

Primary outcome measures

  • Occurrence of adverse events [Time frame: 6 months]
  • Occurrence of surgical complications [Time frame: 6 months]
  • Occurrence of device deficiencies [Time frame: 6 months]
  • Pain [Time frame: 6 months]
Secondary outcome measures (4)
  • Objective Device effectiveness [Time frame: 6 months]
  • Subjective Device effectiveness [Time frame: 6 months]
  • Erectile function recovery [Time frame: 6 months]
  • Delineation of the surgical implantation procedure [Time frame: 6 months]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 4 centers
  • St. Vincent's Private Hospital — Fitzroy
  • Royal Melbourne Hospital — Melbourne
  • Australian Prostate Centre — North Melbourne
  • Epworth HealthCare — Richmond

Identifiers

NCT: NCT05650866 · CP-1.5400

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗