Prevention of Acute Voiding Difficulty After Radical Proctectomy

Overview

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.

Full Title of Study: “Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2010

Detailed Description

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.

Interventions

  • Drug: Tamsulosin
    • oral administration of Tamsulosin

Arms, Groups and Cohorts

  • No Intervention: 1
  • Experimental: 2
    • oral administration of Tamsulosin

Clinical Trial Outcome Measures

Primary Measures

  • Re-insertion rate of urinary catheter after removal
    • Time Frame: after removal of urinary catheter

Secondary Measures

  • Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry
    • Time Frame: at postoperative day 7

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Sung-Bum Kang, Department of Surgery, Seoul National University Bundang Hospital
  • Overall Official(s)
    • Sung-Bum Kang, M.D., Ph.D, Principal Investigator, Seoul National University Bundang Hospital

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