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Prevention of Acute Voiding Difficulty After Radical Proctectomy

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00606983
First received: January 22, 2008
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Urinary Retention
 Drug: Tamsulosin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Re-insertion rate of urinary catheter after removal [ Time Frame: after removal of urinary catheter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry [ Time Frame: at postoperative day 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
oral administration of Tamsulosin
 Drug: Tamsulosin
oral administration of Tamsulosin

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606983

Locations
Korea, Republic of
Department of Surgery, Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sung-Bum Kang, M.D., Ph.D Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Sung-Bum Kang, Department of Surgery, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00606983     History of Changes
Other Study ID Numbers: B-0702-042-006, SNUBH-GS-CR3
Study First Received: January 22, 2008
Last Updated: July 18, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Rectal Neoplasms
Urinary Retention
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
 Urination Disorders
Urologic Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013