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

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05650866
• Other study ID #: CP-1.5400
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: May 19, 2024

Study information

• Verified date: January 2024
• Source: Comphya Australia
• Contact: Fiona Joseph
• Phone: +41 21 693 9517
• Email: fiona.joseph[@]comphya.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 19, 2024
• Est. primary completion date: May 19, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

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).

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	Australian Prostate Centre	North Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Comphya Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	Adverse events will be reported using MedDRA terminology.	6 months
Primary	Occurrence of surgical complications	Surgical complications will be ranked according to the Clavien-Dindo classification	6 months
Primary	Occurrence of device deficiencies	Device deficiencies will be systematically reported and recorded.	6 months
Primary	Pain	Patients will be asked to rate pain on a visual analog scale (from 0 to 10)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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