The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer

Study Overview
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Brief Summary
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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.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Placebo drug
* Drug: Udenafil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Individuals who take placebo after total mesorectal excision | Drug: Placebo drug<br>* After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.<br>|
| Experimental: Udenafil<br>Individuals who take udenafil after total mesorectal excision | Drug: Udenafil<br>* After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week | 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. | Baseline, 12weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in SEP Q2,Q3 and GEQ | 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). | baseline, 12weeks, and 24 weeks | 
| Number of patients with adverse events during 24 weeks of the study |  | Baseline through 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Udenafil, rectal cancer, penile rehabilitation, total mesorectal excision