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Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial


Phase 2
19 Years
70 Years
Not Enrolling
Male
Erectile Dysfunction, Sigmoid Colon Cancer, Rectal Cancer

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Trial Information

Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

at 4 weeks after enrollment

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital

Authority:

South Korea: Institutional Review Board

Study ID:

B-0610-038-004

NCT ID:

NCT00607282

Start Date:

March 2009

Completion Date:

January 2012

Related Keywords:

  • Erectile Dysfunction
  • Sigmoid Colon Cancer
  • Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Erectile Dysfunction
  • Sigmoid Neoplasms

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