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

Study Overview
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Brief Summary
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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.

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

Conditions
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Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
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* Device: Activation of pro-erectile nerves within the pelvic plexus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men of ages between 30-65 years; Men with indication for nerve-sparing prostatectomy surgery; Cancer stage T1c and T2a; Gleason score 6 or 7 (but only 3+4); International Index of Erectile Function (IIEF-15) 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 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).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |