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

Phase 4

Completed

• Conditions: Rectal Cancer
• Interventions: Drug: Placebo drug; Drug: Udenafil

• Registration Number: NCT01421940
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-21
• Study First Posted: 2011-08-23
• Primary Completion: 2011-12
• Study Completion: 2013-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo drug	Individuals who take placebo after total mesorectal excision
Udenafil	Udenafil	Individuals who take udenafil after total mesorectal excision

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	* 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).

Trial Locations

Locations (1)

Kyungpook National University Medical Center; 🇰🇷 Daegu, Korea, Republic of