Prevention of Acute Voiding Difficulty After Radical Proctectomy

Phase 3

Completed

• Conditions: Rectal Cancer; Urinary Retention
• Interventions: Drug: Tamsulosin

• Registration Number: NCT00606983
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-18
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Tamsulosin	oral administration of Tamsulosin

Primary Outcome Measures

Name	Time	Method
Re-insertion rate of urinary catheter after removal	after removal of urinary catheter

Secondary Outcome Measures

Name	Time	Method
Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry	at postoperative day 7

Trial Locations

Locations (1)

Department of Surgery, Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of