Clinical Trial: Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will be evaluated in treatment for patient with chronic erectile dysfunction, which developed after radical resection for sigmoid and rectal cancer and continues 12 months after the surgery.
Detailed Summary:
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.
Sponsor: Seoul National University Hospital
Current Primary Outcome: 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) [ Time Frame: at 4 weeks after enrollment ]
Original Primary Outcome: Improvement of erectile function using IIEF-5 (International Index of Erectile Function-5), SEP Q2 (Sexual Encounter Profile Q2), and GEQ (Global efficacy Question) [ Time Frame: at 4, 8, 12, 16, 20, and 24 weeks after Udenafil treatment ]
Current Secondary Outcome: Improvement of erectile function using IIEF-5, SEP Q2,Q3, and GEQ [ Time Frame: at 12 months after enrollment ]
Original Secondary Outcome: Improvement of erectile function using IIEF-5, SEP Q2, and GEQ [ Time Frame: at 12 months after Udenafil treatment ]
Information By: Seoul National University Hospital
Dates:
Date Received: January 22, 2008
Date Started: March 2009
Date Completion:
Last Updated: September 2, 2012
Last Verified: September 2012
