Erectile Dysfunction Following Radical Prostatectomy Clinical Trial
Official title:
Effect of Early Shockwave Therapy Protocol for Preservation and Restoration of Erectile Function After Nerve-sparing Radical Prostatectomy
This pilot study aims to explore the feasibility, safety and effectiveness of two different extracorporeal shock wave therapy (ESWT) protocols for patients receiving nerve-sparing radical prostatectomy (RP).
This is an open-label, randomized, 2-parallel-arm trial (n=94). All patients will receive (A)
sham (n=47) or (B) active ESWT (n=47) twice/week for 6 weeks (12 sessions total).
Concurrently, all patients will receive daily tadalafil 5mg for 24 weeks. Patients will then
undergo a 4 week washout period without erectogenic aids, and return for a 28-week
evaluation. Subsequently, patients requiring further erectogenic aids after 28 weeks will be
offered intracavernosal injections (ICI) of prostaglandin E1 (PGE1).
Random assignment will be performed by computer program (eg. randomizer.org), in a design
that obtains equal sample size per group.
All patients will be followed for a period of 24 months post-RP. Follow-up protocol includes
evaluation of the IIEF, EHS, GAQ, ICI usage and tolerability, stretched flaccid penile
length, urinary incontinence, and oncologic status.
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