SAFE Technique for Erectile Dysfunction
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy or if PDE5 inhibitors are not safe for you, you cannot participate in the trial.
What data supports the effectiveness of the SAFE Technique for Erectile Dysfunction treatment?
The research indicates that while robotic-assisted radical prostatectomy (RALP) offers some benefits in surgical precision and recovery, erectile dysfunction remains a common issue post-surgery. Modified surgical techniques and nerve-sparing approaches have shown some promise in improving erectile function, but the effectiveness of the SAFE technique specifically is not directly supported by the provided data.12345
Is the SAFE Technique for Erectile Dysfunction safe for humans?
The research on robotic-assisted laparoscopic radical prostatectomy (RALP) suggests it is generally safe, with benefits like decreased surgical complications and faster recovery. However, erectile dysfunction remains a common issue post-surgery, and while treatments like PDE5 inhibitors are used, their long-term benefits are uncertain.12367
How does the SAFE Technique for Erectile Dysfunction differ from other treatments?
The SAFE Technique involves robotic-assisted radical prostatectomy (RALP), which is a surgical method that offers improved precision and potentially better potency rates compared to traditional open surgery. However, erectile dysfunction remains a common issue post-surgery, and while nerve-sparing techniques can help, many patients still require additional treatments like penile prosthesis or medications.12358
Research Team
Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.)
Principal Investigator
Study Principal Investigator
Eligibility Criteria
This trial is for men with localized prostate cancer who are undergoing robotic-assisted radical prostatectomy (RALP). It aims to improve post-surgery erectile function and urinary continence. Specific details on inclusion or exclusion criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Robotic-Assisted Laparoscopic Prostatectomy (RALP) with or without the SAFE technique
Follow-up
Participants are monitored for erectile function recovery and other health outcomes
Treatment Details
Interventions
- Robotic-assisted radical prostatectomy (RALP)
- SAFE (Saline assisted fascial engorgement)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor