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

Rectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421940
• Other study ID #: KNUHCRC002
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2011
• Last updated: March 9, 2015
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Drug:
• Placebo drug
After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.
• Udenafil
After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of patients with adverse events during 24 weeks of the study		Baseline through 24 weeks	Yes