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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sung-Bum Kang, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00607282
First received: January 22, 2008
Last updated: September 2, 2012
Last verified: September 2012

January 22, 2008
September 2, 2012
March 2009
January 2012   (final data collection date for primary outcome measure)
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) [ Time Frame: at 4 weeks after enrollment ] [ Designated as safety issue: No ]
Improvement of erectile function using IIEF-5 (International Index of Erectile Function-5), SEP Q2 (Sexual Encounter Profile Q2), and GEQ (Global efficacy Question) [ Time Frame: at 4, 8, 12, 16, 20, and 24 weeks after Udenafil treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00607282 on ClinicalTrials.gov Archive Site
Improvement of erectile function using IIEF-5, SEP Q2,Q3, and GEQ [ Time Frame: at 12 months after enrollment ] [ Designated as safety issue: No ]
Improvement of erectile function using IIEF-5, SEP Q2, and GEQ [ Time Frame: at 12 months after Udenafil treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer
Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Erectile Dysfunction
  • Sigmoid Colon Cancer
  • Rectal Cancer
Drug: Udenafil
oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)
Other Name: Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea
  • Placebo Comparator: Placebo
    normal control group
    Intervention: Drug: Udenafil
  • Experimental: Udenafil
    oral administration of placebo for Udenafil (Dong-A Pharmaceutical co., Ltd, Seoul, Korea)
    Intervention: Drug: Udenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
January 2012
January 2012   (final data collection date for primary outcome measure)

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)
Male
19 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00607282
B-0610-038-004, SNUBH-GS-CR2
Yes
Sung-Bum Kang, Seoul National University Bundang Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Sung-Bum Kang, M.D., Ph.D Seoul National University Bundang Hospital
Seoul National University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP