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

NCT01421940 | Completed Phase 4 DMC

• 1 other identifier: KNUHCRC002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Udenafil; rectal cancer; penile rehabilitation; total mesorectal excision

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12weeks, 24 weeks

Secondary Outcomes (2)

• Change from baseline in SEP Q2,Q3 and GEQ

  baseline, 12weeks, and 24 weeks

• Number of patients with adverse events during 24 weeks of the study

  Baseline through 24 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Individuals who take placebo after total mesorectal excision

Drug: Placebo drug

Udenafil

EXPERIMENTAL

Individuals who take udenafil after total mesorectal excision

Drug: Udenafil

Interventions

Placebo drug DRUG

After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.

Control

Udenafil DRUG

After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.

Udenafil

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National University Medical Center

Daegu, 702-210, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25482466 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

udenafil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Cancer Center

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 23, 2011
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: October 1, 2013
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

KR (1)