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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Device: Activation of pro-erectile nerves within the pelvic plexus

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Crowe; Phone Number: +61 3 8373 7600; Email: helenrcrowe@gmail.com

Study Locations

• Australia
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Active, not recruiting
      • St. Vincent's Private Hospital
    • Melbourne, Victoria, Australia, 3050
      • Active, not recruiting
      • Royal Melbourne Hospital
    • North Melbourne, Victoria, Australia, 3051
      • Recruiting
      • Australian Prostate Centre
      • Contact: Helen Crowe; Phone Number: +61 (03) 8373 7600; Email: helenrcrowe@gmail.com
    • Richmond, Victoria, Australia, 3121
      • Active, not recruiting
      • Epworth Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implanted group; 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; 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.
No Intervention: Control group; Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Device effectiveness	Erectile response obtained when activating the study device will be objectively assessed by measuring penile rigidity with the RigiScan device.	6 months
Subjective Device effectiveness	Erectile function will be subjectively assessed by asking participants to complete validated questionnaires (International Index of Erectile Function, IIEF-15 and Erection Hardness Score, EHS).	6 months
Erectile function recovery	Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of recovery of natural erectile function.	6 months
Delineation of the surgical implantation procedure	The surgeon will record information related to the implantation (duration, position of the device, grading ease of implantation steps, and any comments).	6 months

Collaborators and Investigators

• Sponsor: Comphya Australia

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: CP-1.5400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No