Prevention of Acute Voiding Difficulty After Radical Proctectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Rectal Cancer, Urinary Retention

Intervention / Treatment
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* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br>oral administration of Tamsulosin | Drug: Tamsulosin<br>* oral administration of Tamsulosin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-insertion rate of urinary catheter after removal |  | after removal of urinary catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry |  | at postoperative day 7 |