Clinical trial NCT00606983: Prevention of Acute Voiding Difficulty After Radical Proctectomy
Official title: Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer
Urinary Retention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Re-insertion rate of urinary catheter after removal
timeFrame: after removal of urinary catheter
Secondary outcomes:
measure: Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry
timeFrame: at postoperative day 7
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sung-Bum Kang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.