The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
Overview
- Phase
- Phase 4
- Intervention
- Placebo drug
- Conditions
- Rectal Cancer
- Sponsor
- Kyungpook National University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Gyu-Seog Choi
Colorectal Cancer Center
Kyungpook National University Hospital
Eligibility Criteria
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)
Arms & Interventions
Control
Individuals who take placebo after total mesorectal excision
Intervention: Placebo drug
Udenafil
Individuals who take udenafil after total mesorectal excision
Intervention: Udenafil
Outcomes
Primary Outcomes
Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
Time Frame: 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 Outcomes
- Number of patients with adverse events during 24 weeks of the study(Baseline through 24 weeks)
- Change from baseline in SEP Q2,Q3 and GEQ(baseline, 12weeks, and 24 weeks)