Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer
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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 |
- 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, 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00607282
| Korea, Republic of | |
| Department of Surgery, Seoul National University Bundang Hospital | |
| Seongnam, Korea, Republic of, 463-707 | |
| 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 Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders Udenafil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors |
ClinicalTrials.gov processed this record on February 26, 2015