Looking for volunteers
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
NCT06945315 · Icahn School of Medicine at Mount Sinai · Updated 25 April 2025
- What is being tested
- RALP (Robotic-assisted radical prostatectomy); SAFE (Saline assisted fascial engorgement)
- For
- Prostate Cancer; Erectile Dysfunction
- Kind of study
- Tests a treatment or device on volunteers. Phase 3.
- Who can join
- Ages 18 years and older. About 196 people. The full rules are on the registry page.
- Where
- United States
- When
- Starts or started 14 Nov 2023, ends 14 July 2027. Registered 25 April 2025.
- Results
- None posted yet.
In the researchers' words
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…
Sites
- Mount Sinai HospitalNew York, New York, United States
