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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
St. Vincent's Private Hospital
Fitzroy, Victoria, Australia
ACTIVE_NOT_RECRUITINGRoyal Melbourne Hospital
Melbourne, Victoria, Australia
ACTIVE_NOT_RECRUITINGAustralian Prostate Centre
North Melbourne, Victoria, Australia
RECRUITINGEpworth HealthCare
Richmond, Victoria, Australia
ACTIVE_NOT_RECRUITINGOccurrence of adverse events
Adverse events will be reported using MedDRA terminology.
Time frame: 6 months
Occurrence of surgical complications
Surgical complications will be ranked according to the Clavien-Dindo classification
Time frame: 6 months
Occurrence of device deficiencies
Device deficiencies will be systematically reported and recorded.
Time frame: 6 months
Pain
Patients will be asked to rate pain on a visual analog scale (from 0 to 10)
Time frame: 6 months
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
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
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
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
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