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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo drug
Udenafil
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Cancer focused on measuring Udenafil, rectal cancer, penile rehabilitation, total mesorectal excision

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Kyungpook National University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Udenafil

Arm Description

Individuals who take placebo after total mesorectal excision

Individuals who take udenafil after total mesorectal excision

Outcomes

Primary Outcome Measures

Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
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
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

Full Information

First Posted
August 1, 2011
Last Updated
March 9, 2015
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01421940
Brief Title
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Udenafil, rectal cancer, penile rehabilitation, total mesorectal excision

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Individuals who take placebo after total mesorectal excision
Arm Title
Udenafil
Arm Type
Experimental
Arm Description
Individuals who take udenafil after total mesorectal excision
Intervention Type
Drug
Intervention Name(s)
Placebo drug
Intervention Description
After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Udenafil
Intervention Description
After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
Description
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.
Time Frame
Baseline, 12weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in SEP Q2,Q3 and GEQ
Description
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).
Time Frame
baseline, 12weeks, and 24 weeks
Title
Number of patients with adverse events during 24 weeks of the study
Time Frame
Baseline through 24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25482466
Citation
Park SY, Choi GS, Park JS, Kim HJ, Park JA, Choi JI. Efficacy and safety of udenafil for the treatment of erectile dysfunction after total mesorectal excision of rectal cancer: a randomized, double-blind, placebo-controlled trial. Surgery. 2015 Jan;157(1):64-71. doi: 10.1016/j.surg.2014.07.007.
Results Reference
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The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer

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