Prevention of Acute Voiding Difficulty After Radical Proctectomy

Seoul National University

Status and phase

Completed

Phase 3

Conditions

Urinary Retention

Rectal Cancer

Treatments

Drug: Tamsulosin

Study type

Interventional

Funder types

Other

Identifiers

NCT00606983

SNUBH-GS-CR3

B-0702-042-006

Details and patient eligibility

About

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 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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)