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

Phase 3
20 Years
80 Years
Not Enrolling
Rectal Cancer, Urinary Retention

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Trial Information

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

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.

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

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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Re-insertion rate of urinary catheter after removal

Outcome Time Frame:

after removal of urinary catheter

Safety Issue:


Principal Investigator

Sung-Bum Kang, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital


South Korea: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

September 2010

Related Keywords:

  • Rectal Cancer
  • Urinary Retention
  • Rectal Neoplasms
  • Urinary Retention