Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607282
• Other study ID #: B-0610-038-004
• Secondary ID: SNUBH-GS-CR2
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2008
• Last updated: September 2, 2012
• Start date: March 2009
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will be evaluated in treatment for patient with chronic erectile dysfunction, which developed after radical resection for sigmoid and rectal cancer and continues 12 months after the surgery.

Description:

Post-pelvic surgery erectile dysfunction is of much interest to those performing sigmoid colon and rectal cancer surgery and their patients. Erectile dysfunction has been recognized to develop from damage to pelvic parasympathetic nerve, which are especially vulnerable during anterior rectal dissection. There may be also a contribution of psychological factors from the presence of stoma and fear of recurrent cancer. Recently, several studies reported that erectile dysfunction after rectal excision for rectal cancer was completely reversed or satisfactorily improved using oral erectile dysfunction drugs. Udenafil is a new phosphodiesterase type 5 (PDE 5) inhibitor for erectile dysfunction. Prior studies have also demonstrated a selectivity profile for udenafil that is similar to Sildenafil (viagra®) and tadalafil (Cialis®). But unlike tadalafil (Cialis®), it does not significantly inhibit the PDE11 isozyme and not produce significant myalgia. back pain, or leg pain.

This prospective, randomized study was designed to evaluate the efficacy of Udenafil treatment in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In order to conduct this study, enrolled patients will be randomly attributed to Udenafil group or placebo group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• • Male patients between 19-70 years old in good general health

• Patient willing to treat postoperative erectile dysfunction and participate in the study

• Patient who understands and accepts to sign the informed consent form

• Patient who received radical resection for sigmoid colon and rectal cancer. :

erectile dysfunction was developed following operation, not preoperatively

• Scores of IIEF-5 measured at 12 months after surgery is 16 or less

Exclusion Criteria:

• • Documented problem of preoperative erectile dysfunction

• Past history of myocardial infarction, cerebrovascular disease

• Under administration of nitrate

• Liver dysfunction (SGOT or SGPT 100 IU/L or more)

• Kidney dysfunction (serum Creatinine 3mg/dl or more)

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Rectal Cancer
• Rectal Neoplasms
• Sigmoid Colon Cancer

Intervention

Drug:
• Udenafil
oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of erectile function using IIEF-5 (International Index of Erectile Function-5), SEP Q2, Q3 (Sexual Encounter Profile Q2,Q3), and GEQ (Global efficacy Question)		at 4 weeks after enrollment	No
Secondary	Improvement of erectile function using IIEF-5, SEP Q2,Q3, and GEQ		at 12 months after enrollment	No