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Completed

NCT Number: NCT00606983

Prevention of Acute Voiding Difficulty After Radical Proctectomy

Various adrenergic blockers are used for acute voiding difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with rectal cancer after radical proctectomy.

This study is to evaluate the efficacy of pharmacologic prevention to ameliorate the incidence of postoperative urinary dysfunction.

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Key information

About this study

Acute voiding difficulty is caused from damage to pelvic sympathetic nerve after rectal surgery, and usually resolved spontaneously within several months after the surgery. However, acute voiding difficulty results in prolonged insertion of urinary catheter and is associated risk for urinary tract infection. Various adrenergic blockers are used for acute voiding difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with rectal cancer after radical proctectomy.

This study is to evaluate the efficacy of pharmacologic prevention to ameliorate teh incidence of postoperative urinary dysfunction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between 20-80 years old in general good health
  • Patient willing to participate in the study
  • Patient who understands and accepts to sign the informed consent form
  • Patient who received proctectomy for rectal cancer located 15 cm or less of the anal verge

Exclusion criteria

  • Documented problem of preoperative urinary dysfunction
  • Any post-surgery change in patient condition which requires insertion of urinary catheter after surgery
  • Past history of recurrent urinary tract infection or malignancy of urinary system organs
  • Past history of surgery for urinary system organs
  • Current administration of Finasteride or Dutasteride
  • Liver dysfunction (SGOT or SGPT 100 IU/L or more)
  • Kidney dysfunction (serum Creatinine 3mg/dl or more)

Treatment and study plan

Tamsulosin

Drug

oral administration of Tamsulosin

Primary outcomes

  1. Re-insertion rate of urinary catheter after removal

    Time frame: after removal of urinary catheter

Secondary outcomes

  1. Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry

    Time frame: at postoperative day 7

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 5, 2008
Registry last updated
Jul 20, 2011

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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