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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01421940
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rectal Cancer Drug: Placebo drug Drug: Udenafil Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Study Start Date : October 2009
Primary Completion Date : December 2011
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week [ Time Frame: Baseline, 12weeks, 24 weeks ]
    • 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 :
  1. Change from baseline in SEP Q2,Q3 and GEQ [ Time Frame: baseline, 12weeks, and 24 weeks ]
    • 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).

  2. Number of patients with adverse events during 24 weeks of the study [ Time Frame: Baseline through 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421940


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gyu-Seog Choi, Colorectal Cancer Center, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01421940     History of Changes
Other Study ID Numbers: KNUHCRC002
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by Gyu-Seog Choi, 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