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

Study Description

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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 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 or disease	Intervention/treatment	Phase
Erectile Dysfunction; Sigmoid Colon Cancer; Rectal Cancer	Drug: Udenafil	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	46 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	March 2009
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Improvement of erectile function using IIEF-5, SEP Q2,Q3, and GEQ [ Time Frame: at 12 months after enrollment ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	19 Years to 70 Years (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	February 5, 2008
Last Update Posted:	September 5, 2012
Last Verified:	September 2012

Additional relevant MeSH terms:

Rectal Neoplasms; Erectile Dysfunction; Sigmoid Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases	Sexual Dysfunction, Physiological; Genital Diseases, Male; Sexual Dysfunctions, Psychological; Mental Disorders; Colonic Neoplasms; Colonic Diseases; Sigmoid Diseases; Udenafil; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action