SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

About This Trial

This study is testing a new surgical technique that uses high-resolution ultrasound imaging and gentle fluid injections during robotic prostate removal to better protect the nerves responsible for erections.
It is designed for sexually active adult men diagnosed with prostate cancer who are already scheduled to have nerve-sparing prostate surgery.
The goal of this research is to see if this new method helps patients safely regain their sexual function more quickly after surgery.
Before considering this trial, patients should know that those currently taking hormone therapy or having repeat prostate surgery cannot participate.

More Information

Robotic-assisted radical prostatectomy (RALP) has become the Standard of Care in the management of localized prostate cancer.
However, post-prostatectomy erectile dysfunction (ED) and urinary incontinence still pose a challenge that adversely affects the patient's quality of life.
Hydrodissection (HD) was introduced in 1987 in the medical field and it was tested for the first time during a retropubic radical prostatectomy back in 2005.
Since then, research has indicated an improvement in erectile function results, presumably because of a less traumatic neural dissection and a decreased risk of neuropraxia.
In an effort to achieve a balance between oncological excision and functional preservation, prostate surgery is evolving to incorporate intraoperative real-time evaluation of extracapsular extension.
Recently, a micro-ultrasound operating at 29 MHz has been introduced.
It provides a resolution down to 70 μ to assess the glandular pattern and cellular density of the prostatic tissue.
Given the experience in more than a thousand cases with this technology, and the growing literature showing promising results in the detection and staging of prostate cancer; the researchers decided to implement this tool as guidance for hydrodissection of the layers of the lateral prostatic fascia.
Robotic-Assisted Laparoscopic Prostatectomy and SAFE (Saline assisted fascial engorgement) nerve preservation guided by Microultrasound (MUS) is a prospective randomized controlled trial designed to evaluate the impact of normal saline solution hydrodissection (HD) on erectile function outcomes after RALP.
This innovative approach consists of a transrectal ultrasound-guided HD using a high-resolution Microultrasound (MUS) (ExactVu micro-ultrasound, Exact Imaging, Markham, Canada).
The technique will be applied to those patients who undergo grade 1, 2, or 3 NS approach taking into account the grading system proposed by Tewari et al.
The hypothesis is that the SAFE technique could minimize the risk of a traumatic neurovascular bundle dissection while assessing the prostatic capsule integrity with a high-resolution MUS.
The researchers also hypothesize that the use of SAFE along with RALP will optimize the post-surgery recovery of erectile function.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing a new surgical technique that uses high-resolution ultrasound imaging and gentle fluid injections during robotic prostate removal to better protect the nerves responsible for erections.

Study Details

Start Date: November 14, 2023
Lead Sponsor: Icahn School of Medicine at Mount Sinai

Full Eligibility Criteria

Inclusion Criteria

Age > 18 years at the time of consent.
Men who are potent (SHIM ≥ 17) and sexually active, who are planned to undergo a grade 1, 2, or 3 nerve-sparing approaches, as per the grading system during RALP.
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria