Health TrialsbyHealthPanel

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

ConditionErectile Dysfunction Following Radical Prostatectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-70
SponsorComphya Australia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Implanted groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Occurrence of adverse events

Adverse events will be reported using MedDRA terminology.

Time frame
6 months
2

Occurrence of surgical complications

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

Time frame
6 months
3

Occurrence of device deficiencies

Device deficiencies will be systematically reported and recorded.

Time frame
6 months
4

Pain

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

Time frame
6 months

Secondary outcomes

1

Objective Device effectiveness

Erectile response obtained when activating the study device will be objectively assessed by measuring penile rigidity with the RigiScan device.

Time frame
6 months
2

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).

Time frame
6 months
3

Erectile function recovery

Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of recovery of natural erectile function.

Time frame
6 months
4

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).

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Comphya Australia

Lead sponsor

Source ClinicalTrials.gov
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