Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial
Post-pelvic surgery erectile dysfunction is of much interest to those performing sigmoid
colon and rectal cancer surgery and their patients. Erectile dysfunction has been recognized
to develop from damage to pelvic parasympathetic nerve, which are especially vulnerable
during anterior rectal dissection. There may be also a contribution of psychological factors
from the presence of stoma and fear of recurrent cancer. Recently, several studies reported
that erectile dysfunction after rectal excision for rectal cancer was completely reversed or
satisfactorily improved using oral erectile dysfunction drugs. Udenafil is a new
phosphodiesterase type 5 (PDE 5) inhibitor for erectile dysfunction. Prior studies have also
demonstrated a selectivity profile for udenafil that is similar to Sildenafil (viagra®) and
tadalafil (Cialis®). But unlike tadalafil (Cialis®), it does not significantly inhibit the
PDE11 isozyme and not produce significant myalgia. back pain, or leg pain.
This prospective, randomized study was designed to evaluate the efficacy of Udenafil
treatment in treatment of erectile dysfunction after radical resection for sigmoid colon and
rectal cancer. In order to conduct this study, enrolled patients will be randomly attributed
to Udenafil group or placebo group.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Improvement of erectile function using IIEF-5 (International Index of Erectile Function-5), SEP Q2, Q3 (Sexual Encounter Profile Q2,Q3), and GEQ (Global efficacy Question)
at 4 weeks after enrollment
No
Sung-Bum Kang, M.D., Ph.D
Principal Investigator
Seoul National University Bundang Hospital
South Korea: Institutional Review Board
B-0610-038-004
NCT00607282
March 2009
January 2012
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