Prevention of Acute Voiding Difficulty After Radical Proctectomy
Information source: Seoul National University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rectal Cancer; Urinary Retention
Intervention: Tamsulosin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s):
Sung-Bum Kang, M.D., Ph.D, Principal Investigator, Affiliation: Seoul National University Bundang Hospital
Overall contact:
Sung-Bum Kang, M.D., Ph.D, Phone: +82-31-787-7093, Email: kangsb@snubh.org
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.
Clinical Details
Official title: Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Re-insertion rate of urinary catheter after removal
Secondary outcome: Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry
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
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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)
Locations and Contacts
Sung-Bum Kang, M.D., Ph.D, Phone: +82-31-787-7093, Email: kangsb@snubh.org
Department of Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Korea, Republic of; Recruiting
Sung-Bum Kang, M.D., Ph.D, Phone: +82-31-787-7093, Email: kangsb@snubh.org
Duck-Woo Kim, M.D., Sub-Investigator
Additional Information
Starting date: May 2007
Ending date: March 2009
Last updated: February 7, 2009
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