The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01421940
First received: August 1, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.


Condition Intervention Phase
Rectal Cancer
Drug: Placebo drug
Drug: Udenafil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week [ Time Frame: Baseline, 12weeks, 24 weeks ] [ Designated as safety issue: No ]
    • IIEF-5 questionnaire is used to assess male erectile function
    • IIEF-5 (5-item Version of the International Index of Erectile Function)is obtained by combining the scores of the responses to 5 questions. Each question is scored from 0-5 (1 questions is scored from 1-5) for IIEF-5 range of 1-25 points; lower numerical scores from the IIEF-5 questionnaire represnt greater severitt of erectile dysfunction.


Secondary Outcome Measures:
  • Change from baseline in SEP Q2,Q3 and GEQ [ Time Frame: baseline, 12weeks, and 24 weeks ] [ Designated as safety issue: No ]
    • SEP Q2 (Sexual encounter profile Q2) and SEP Q3 (Sexual encounter profile Q3) are used to assess erectile function
    • The efficaty of medication is followed by GEQ (Global efficacy question).

  • Number of patients with adverse events during 24 weeks of the study [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Individuals who take placebo after total mesorectal excision
Drug: Placebo drug
After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.
Experimental: Udenafil
Individuals who take udenafil after total mesorectal excision
Drug: Udenafil
After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age : 20-65
  • Rectal cancer within 15cm from anal verge
  • Patients with more than 5 points decreased IIEF-5 after operation
  • Patients with sexual activity

Exclusion Criteria:

  • Preoperative IIEF-5 : ≤14
  • Recent MI, CVA, nitrate medication
  • Severe cardiovascular disease, psychiatric disease
  • Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
  • Renal dysfunction (Cr ≥2mg/dl)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421940

Locations
Korea, Republic of
Kyungpook National University Medical Center
Daegu, Korea, Republic of, 702-210
Sponsors and Collaborators
Kyungpook National University
  More Information

No publications provided

Responsible Party: Gyu-Seog Choi, Colorectal Cancer Center, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01421940     History of Changes
Other Study ID Numbers: KNUHCRC002
Study First Received: August 1, 2011
Last Updated: July 11, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
Udenafil
rectal cancer
penile rehabilitation
total mesorectal excision

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014