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Completed

NCT Number: NCT01421940

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

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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Kyungpook National University Medical Center

Daegu, 702-210, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo drug

Drug

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

Udenafil

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Aug 23, 2011
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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