20 Years
65 Years
Male
Rectal Cancer
Trial Information
Inclusion Criteria:
- Age : 20-65
- Rectal cancer within 15cm from anal verge
- Patients with more than 5 points decreased IIEF-5 after operation
- Patients with sexual activity
Exclusion Criteria:
- Preoperative IIEF-5 : ≤14
- Recent MI, CVA, nitrate medication
- Severe cardiovascular disease, psychiatric disease
- Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- Renal dysfunction (Cr ≥2mg/dl)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
Outcome Description:
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.
Outcome Time Frame:
Baseline, 12weeks, 24 weeks
Safety Issue:
No
Authority:
South Korea: Institutional Review Board
Study ID:
KNUHCRC002
NCT ID:
NCT01421940
Start Date:
October 2009
Completion Date:
October 2012
Related Keywords:
- Rectal Cancer
- Udenafil
- rectal cancer
- penile rehabilitation
- total mesorectal excision
- Rectal Neoplasms
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