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

NCT05650866 | Recruiting

• 1 other identifier: CP-1.5400
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (4)

• Occurrence of adverse events

  Adverse events will be reported using MedDRA terminology.

  6 months

• Occurrence of surgical complications

  Surgical complications will be ranked according to the Clavien-Dindo classification

  6 months

• Occurrence of device deficiencies

  Device deficiencies will be systematically reported and recorded.

  6 months

• Pain

  Patients will be asked to rate pain on a visual analog scale (from 0 to 10)

  6 months

Secondary Outcomes (4)

• Objective Device effectiveness

  6 months

• Subjective Device effectiveness

  6 months

• Erectile function recovery

  6 months

• Delineation of the surgical implantation procedure

  6 months

Study Arms (2)

Implanted group

EXPERIMENTAL

The study device will be implanted during the ongoing prostatectomy surgery. Participants will then be asked to activate it everyday.

Device: Activation of pro-erectile nerves within the pelvic plexus

Control group

NO INTERVENTION

Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device.

Interventions

Activation of pro-erectile nerves within the pelvic plexus DEVICE

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.

Implanted group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Gender eligibility: male. Not based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Comphya Australia: lead

Study Sites (4)

St. Vincent's Private Hospital

Fitzroy, Victoria, 3065, Australia

ACTIVE NOT RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

ACTIVE NOT RECRUITING

Australian Prostate Centre

North Melbourne, Victoria, 3051, Australia

RECRUITING

Epworth HealthCare

Richmond, Victoria, 3121, Australia

ACTIVE NOT RECRUITING

Central Study Contacts

Helen Crowe

CONTACT

+61 3 8373 7600; helenrcrowe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 14, 2022
• Study Start: May 19, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)