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

NCT ID: NCT05650866

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2025-05-19

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implanted group

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

Group Type: EXPERIMENTAL

Activation of pro-erectile nerves within the pelvic plexus

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Comphya Australia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Vincent's Private Hospital

Fitzroy, Victoria, Australia

Site Status: ACTIVE_NOT_RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status: ACTIVE_NOT_RECRUITING

Australian Prostate Centre

North Melbourne, Victoria, Australia

Site Status: RECRUITING

Epworth HealthCare

Richmond, Victoria, Australia

Site Status: ACTIVE_NOT_RECRUITING

Countries

Australia

Central Contacts

Fiona Joseph

Role: CONTACT

fiona.joseph@comphya.com

+41 21 693 9517

Facility Contacts

Helen Crowe

Role: primary

helenrcrowe@gmail.com

+61 (03) 8373 7600

Other Identifiers

CP-1.5400

Identifier Type: -

Identifier Source: org_study_id