Rectal Cancer
Conditions
Keywords
Udenafil, rectal cancer, penile rehabilitation, total mesorectal excision
Brief summary
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.
Interventions
DRUGPlacebo drug
After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.
DRUGUdenafil
After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.
Sponsors
Kyungpook National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week | Baseline, 12weeks, 24 weeks | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in SEP Q2,Q3 and GEQ | baseline, 12weeks, and 24 weeks | * 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 | Baseline through 24 weeks | — |
Countries
South Korea
Outcome results
None listed