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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Rectal Cancer; Sigmoid Colon Cancer
• Intervention / Treatment: Drug: Udenafil

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 463-707
    • Department of Surgery, Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; normal control group	Drug: Udenafil; oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months); Other Names: 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 Names: Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement of erectile function using IIEF-5, SEP Q2,Q3, and GEQ	at 12 months after enrollment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 22, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (Estimate): February 5, 2008

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 2, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Sigmoid Diseases; Colonic Neoplasms; Erectile Dysfunction; Rectal Neoplasms; Sigmoid Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Udenafil
• Other Study ID Numbers: B-0610-038-004; SNUBH-GS-CR2