The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
- Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week [ Time Frame: Baseline, 12weeks, 24 weeks ] [ Designated as safety issue: No ]
- IIEF-5 questionnaire is used to assess male erectile function
- IIEF-5 (5-item Version of the International Index of Erectile Function)is obtained by combining the scores of the responses to 5 questions. Each question is scored from 0-5 (1 questions is scored from 1-5) for IIEF-5 range of 1-25 points; lower numerical scores from the IIEF-5 questionnaire represnt greater severitt of erectile dysfunction.
- Change from baseline in SEP Q2,Q3 and GEQ [ Time Frame: baseline, 12weeks, and 24 weeks ] [ Designated as safety issue: No ]
- SEP Q2 (Sexual encounter profile Q2) and SEP Q3 (Sexual encounter profile Q3) are used to assess erectile function
- The efficaty of medication is followed by GEQ (Global efficacy question).
- Number of patients with adverse events during 24 weeks of the study [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||October 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Control
Individuals who take placebo after total mesorectal excision
Drug: Placebo drug
After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.
Individuals who take udenafil after total mesorectal excision
After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421940
|Korea, Republic of|
|Kyungpook National University Medical Center|
|Daegu, Korea, Republic of, 702-210|