SAFE Technique for Erectile Dysfunction

Overseen By Monali Fatterpekar, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Androgen deprivation therapy

Disqualifiers: Salvage RALP candidates, PDE5 inhibitors contraindicated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 day (surgery)

196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technique to help men regain erectile function after prostate surgery. Researchers are examining the SAFE technique, which uses saline and high-resolution ultrasound, to improve recovery after robotic-assisted radical prostatectomy (RALP). They aim to determine if this approach can better protect nerves and enhance erectile function post-surgery. Men who are sexually active and planning specific nerve-sparing prostate surgeries might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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 prior data suggests that the SAFE technique is safe for erectile function recovery?

Research has shown that the SAFE technique, when combined with robotic-assisted prostate surgery, might better protect nerves. This could improve the chances of maintaining erectile function after surgery. Previous studies found that men who underwent the SAFE method often reported better erectile function up to a year post-surgery.

In these studies, men in the SAFE group required fewer additional treatments, such as injections, for erectile function compared to those who did not use the SAFE method. This suggests that the technique is gentle on the body and may reduce the risk of nerve damage during surgery.

While these results are encouraging, it is important to note that this information comes from past studies. The current trial is ongoing to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAFE Technique for erectile dysfunction because it introduces a novel approach to enhancing recovery after prostate surgery. While standard treatments for erectile dysfunction often rely on medications like Viagra or penile implants, the SAFE Technique involves a unique method called saline-assisted fascial engorgement during robotic-assisted prostate surgery. This technique aims to improve blood flow and tissue health in a way that existing treatments don't address, potentially leading to better and faster recovery of erectile function. By integrating this innovative method with robotic surgery, there's hope for improved outcomes for patients undergoing prostate surgery.

What evidence suggests that the SAFE technique is effective for erectile dysfunction?

This trial will compare the SAFE technique in robotic-assisted prostate surgery to surgery without it. Research has shown that the SAFE technique can improve erectile function post-operation when used with robotic-assisted prostate surgery. Specifically, studies found that patients who underwent the SAFE technique scored better on erectile function tests at 6, 13, 26, and 52 weeks after surgery. This improvement likely results from the technique causing less nerve damage during the procedure. It uses a saltwater solution to enhance visibility and protect nerves, aiding in the maintenance of erectile function. Overall, the SAFE technique appears promising in helping patients regain better sexual function after prostate surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.)

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

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

Ability to understand and the willingness to sign a written informed consent

I am over 18 years old.

I am a man with normal sexual function undergoing a specific prostate surgery.

Exclusion Criteria

I am a candidate for a repeat prostate surgery.

I am currently on hormone therapy for cancer.

I cannot take PDE5 inhibitors due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Robotic-Assisted Laparoscopic Prostatectomy (RALP) with or without the SAFE technique

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for erectile function recovery and other health outcomes

24 months

Multiple visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Robotic-assisted radical prostatectomy (RALP)
• SAFE (Saline assisted fascial engorgement)

Trial Overview The trial tests the SAFE technique, which uses saline during surgery to protect nerves, guided by high-resolution micro-ultrasound. The goal is to reduce trauma during nerve dissection and enhance recovery of erectile function after RALP.

How Is the Trial Designed?

Group I: RALP with SAFE Technique Experimental Treatment 2 Interventions

Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) + SAFE (Saline assisted fascial engorgement).

Group II: RALP without SAFE Technique Active Control 1 Intervention

Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) without SAFE (Saline assisted fascial engorgement).

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Robotic-assisted laparoscopic prostatectomy (RALP) demonstrated high safety with no conversions to open surgery or re-operations in the first 100 cases studied, with an average blood loss of only 281 ml and a short hospital stay of 1.1 nights.

Efficacy results showed an 18% positive margin rate overall, with only 8% for pT2 tumors, and 68% of patients reported no incontinence at 12 months, indicating RALP is effective in managing prostate cancer with favorable postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: a 2010 update. Duthie, JB., Pickford, JE., Gilling, PJ.[2011]

Citations

1. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16238

Saline‐assisted fascial exposure (SAFE) technique to improve ... Our analysis revealed statistically significant differences in EF outcomes in favour of RALP + SAFE across the SHIM categories at 6, 13, 26, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06945315

SAFE Nerve Sparing Guided by Micro-ultrasound (MUS) SAFE (Saline assisted fascial engorgement) an innovative technique to achieve enhanced nerve-sparing outcomes among patients undergoing robot-assisted ...

3. mountsinai.org mountsinai.org/clinical-trials/safe-nerve-sparing-guided-by-micro-ultrasound-mus

SAFE Nerve Sparing Guided by Micro-ultrasound (MUS) Since then, research has indicated an improvement in erectile function results, presumably because of a less traumatic neural dissection and a decreased risk of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38062880/

Saline-assisted fascial exposure (SAFE) technique to ... Conclusions: The use of the SAFE technique led to better SHIM scores at 6, 13, 26, and 52 weeks after RALP in patients at high risk of ECE who underwent a ...

5. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/abs/10.1111/bju.16238

Saline‐assisted fascial exposure (SAFE) technique to improve ... The use of the SAFE technique led to better SHIM scores at 6, 13, 26, and 52 weeks after RALP in patients at high risk of ECE who underwent a partial NS ...

6. liebertpub.com liebertpub.com/doi/abs/10.1089/vid.2022.0025

Saline-Assisted Fascial Engorgement Nerve Preservation ... Potent patients in the SAFE group did not require intracavernosal injections (ICIs), whereas two patients in the control group needed ICI at 3 months follow-up.