Rectal Cancer, Urinary Retention
Conditions
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.
Interventions
DRUGTamsulosin
oral administration of Tamsulosin
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Re-insertion rate of urinary catheter after removal | after removal of urinary catheter |
Secondary
| Measure | Time frame |
|---|---|
| Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry | at postoperative day 7 |
Countries
South Korea
Outcome results
None listed