Efficacy of Udenafil After Radical Proctectomy - Full Text View

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00607282

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 proctectomy for rectal cancer. In this study, the efficacy of Udenafil will be evaluated in 2 different patients groups: 1) treatment for patient with chronic erectile dysfunction, which developed after proctectomy and continues 6 months after the surgery, 2) early rehabilitation therapy for patients with acute erectile dysfunction following proctectomy, in which oral administration of Udenafil is decided based on the evaluation of sexual function at 4 weeks after the surgery.

Condition	Intervention	Phase
Erectile Dysfunction Rectal Cancer	Drug: Udenafil	Phase III

MedlinePlus related topics: Cancer Erectile Dysfunction Surgery

Drug Information available for: DA-8159

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Proctectomy for Rectal Cancer

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 (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 ]

Secondary Outcome Measures:

Improvement of erectile function using IIEF-5, SEP Q2, and GEQ [ Time Frame: at 12 months after Udenafil treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	October 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention
2: Experimental oral administration of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea)	Drug: Udenafil oral administration of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea)

Detailed Description:

Postproctectomy erectile dysfunction is of much interest to those performing 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 proctectomy for 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:	20 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male patients between 20-65 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 proctectomy for rectal cancer located 15 cm or less of the anal verge
- Erectile dysfunction was developed following proctectomy for rectal cancer, not preoperatively
- Scores of IIEF-5 measured at 12 months after surgery is 17 or less (only in chronic erectile dysfunction group)
- Scores of IIEF-5 measured at 4 weeks after surgery decreases 5 points or more compared to baseline preoperative scores (only in acute erectile dysfunction)

Exclusion Criteria:

• Documented problem of preoperative erectile dysfunction
- Preoperative scores of IIEF-5 is 14 or less
- 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

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

Contacts

Contact: Sung-Bum Kang, M.D., Ph.D

+82-31-787-7093

kangsb@snubh.org

Locations

Korea, Republic of
Department of Surgery, Seoul National University Bundang Hospital	Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Sung-Bum Kang, M.D., Ph.D +82-31-787-7093 kangsb@snubh.org
Sub-Investigator: Duck-Woo Kim, M.D.

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:	Department of Surgery, Seoul National University Bundang Hospital ( Sung-Bum Kang )
Study ID Numbers:	B-0610-038-004, SNUBH-GS-CR2
Study First Received:	January 22, 2008
Last Updated:	February 7, 2009
ClinicalTrials.gov Identifier:	NCT00607282
Health Authority:	South Korea: Institutional Review Board

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Genital Diseases, Male
Rectal Diseases
Intestinal Neoplasms

Rectal neoplasm
Digestive System Diseases
Sexual Dysfunction, Physiological
Mental Disorders
Gastrointestinal Neoplasms
Rectal cancer
Erectile Dysfunction
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on February 12, 2009