SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2025 by Icahn School of Medicine at Mount Sinai
Sponsor
Icahn School of Medicine at Mount Sinai
Information Provided by (Responsible Party)
Ashutosh Kumar Tewari
Clinicaltrials.gov Identifier
NCT06945315
Other Study ID Numbers:
STUDY-22-01522
First Submitted
April 17, 2025
First Posted
April 24, 2025
Last Update Posted
April 24, 2025
Last Verified
March 2025

ClinicalTrials.gov processed this data on April 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Prostate CancerErectile Dysfunction
Procedure: RALP (Robotic-assisted radical prostatectomy)Procedure: RALP (Robotic-assisted radical prostatectomy)

Study Design

Study TypeInterventional
Actual Enrollment196 participants
Design AllocationRandomized
Interventional ModelSingle Group Assignment
MaskingDouble
Primary PurposePrevention
Official TitleRobotic-Assisted Laparoscopic Prostatectomy (RALP) and SAFE (Saline Assisted Fascial Engorgement) Nerve Preservation Guided by Micro-ultrasound: A Phase III RCT
Study Start DateNovember 13, 2023
Actual Primary Completion Date1yr 1mo from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
RALP with SAFE Technique
Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) + SAFE (Saline assisted fascial engorgement).
Procedure: RALP (Robotic-assisted radical prostatectomy)
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.
RALP without SAFE Technique
Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) without SAFE (Saline assisted fascial engorgement).
Procedure: RALP (Robotic-assisted radical prostatectomy)
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.

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsIcahn School of Medicine at Mount Sinai
Locations
Mount Sinai Hospital | New York New York, United States, 10029
Investigators
Principal Investigator: Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.), Study Principal Investigator