Status:

COMPLETED

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

Lead Sponsor:

Seoul National University Hospital

Conditions:

Erectile Dysfunction

Sigmoid Colon Cancer

Eligibility:

MALE

19-70 years

Phase:

PHASE2

Brief 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...

Detailed 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 da...

Eligibility Criteria

Inclusion

  • • 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

  • • 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)

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2012

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00607282

Start Date

March 1 2009

End Date

January 1 2012

Last Update

September 5 2012

Active Locations (1)

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1

Department of Surgery, Seoul National University Bundang Hospital

Seongnam, South Korea, 463-707