SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

Phase 3RecruitingNCT06945315

Icahn School of Medicine at Mount Sinai196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

RALP (Robotic-assisted radical prostatectomy)PROCEDURE

Robotic-assisted radical prostatectomy (RALP) is a standard surgical procedure for managing localized prostate cancer that focuses on prostate anatomy and surrounding structures to enable personalized surgeries. The procedure incorporates nerve-sparing techniques through careful dissection of the neurovascular bundle and can use a thermal and traction-free dissection to improve functional outcomes, particularly erectile function.

SAFE (Saline assisted fascial engorgement)DRUG

SAFE (Saline assisted fascial engorgement) an innovative technique to achieve enhanced nerve-sparing outcomes among patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Essentially a new method of hydro dissection, SAFE involves an injection of 30 cc of normal saline solution between the layers of the periprostatic fascia after early release of the neurovascular bundle. This injection effectively pushes the nerves away from the prostate, enabling a dissection of the prostate that is atraumatic vis a vis the neural hammock.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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: * Subjects who are candidates for salvage RALP * Subjects on androgen deprivation therapy (ADT) * Subjects in whom PDE5 inhibitors are contraindicated

Outcomes

Primary Outcomes

Sexual Health Inventory for Men (SHIM)

The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. It is graded on a scale of 1-25, with higher scores indicating no signs of erectile dysfunction.

Time frame: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery

Secondary Outcomes

The Erection Hardness Score (EHS)

The Erection Hardness Score (EHS) is tool used to evaluate and monitor the severity of ED. It is a four-point scale (1-4), with a score of 4 indicating a completely hard and fully rigid erection. Higher score indicates better health outcomes.