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
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Sigmoid Colon Cancer
Rectal Cancer
Drug: Udenafil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Improvement of erectile function using IIEF-5, SEP Q2,Q3, and GEQ [ Time Frame: at 12 months after enrollment ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: March 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
normal control group
Drug: Udenafil
oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)
Other Name: Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea
Experimental: Udenafil
oral administration of placebo for Udenafil (Dong-A Pharmaceutical co., Ltd, Seoul, Korea)
Drug: Udenafil
oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)
Other Name: Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea

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 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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607282

Locations
Korea, Republic of
Department of Surgery, Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sung-Bum Kang, M.D., Ph.D Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Sung-Bum Kang, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00607282     History of Changes
Other Study ID Numbers: B-0610-038-004, SNUBH-GS-CR2
Study First Received: January 22, 2008
Last Updated: September 2, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Erectile Dysfunction
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Intestinal Diseases
Intestinal Neoplasms
Mental Disorders
Neoplasms
Neoplasms by Site
Rectal Diseases
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Udenafil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014