SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

Recruiting Phase 3 Interventional Study
Prostate Cancer Erectile Dysfunction
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
196 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
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About 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 retropu…
Trial Locations
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Eligibility Criteria
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 c…
Contacts

Neeraja Tillu

(332) 256-8528

Neeraja.tillu@mountsinai.org

CONTACT

Monali Fatterpekar, PhD

(212) 241-0751

monali.fatterpekar@mountsinai.org

CONTACT