Prevention of Acute Voiding Difficulty After Radical Proctectomy - Full Text View

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00606983

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin

Resource links provided by NLM:

MedlinePlus related topics: Cancer Urine and Urination

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

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
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention
2: Experimental 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

Contacts

Contact: Sung-Bum Kang, M.D., Ph.D

+82-31-787-7093

kangsb@snubh.org

Locations

Korea, Republic of
Department of Surgery, Seoul National University Bundang Hospital	Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Sung-Bum Kang, M.D., Ph.D +82-31-787-7093 kangsb@snubh.org
Sub-Investigator: Duck-Woo Kim, M.D.

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:	Department of Surgery, Seoul National University Bundang Hospital ( Sung-Bum Kang )
Study ID Numbers:	B-0702-042-006, SNUBH-GS-CR3
Study First Received:	January 22, 2008
Last Updated:	February 7, 2009
ClinicalTrials.gov Identifier:	NCT00606983 History of Changes
Health Authority:	South Korea: Institutional Review Board

Study placed in the following topic categories:

Neurotransmitter Agents
Digestive System Neoplasms
Adrenergic Agents
Rectal Neoplasms
Gastrointestinal Diseases
Urination Disorders
Rectal Neoplasm
Adrenergic alpha-Antagonists
Urinary Retention
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Urologic Diseases
Tamsulosin
Gastrointestinal Neoplasms
Adrenergic Antagonists
Colorectal Neoplasms

Additional relevant MeSH terms:

Neurotransmitter Agents
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Rectal Neoplasms
Gastrointestinal Diseases
Urination Disorders
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Urinary Retention
Intestinal Diseases

Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Urologic Diseases
Therapeutic Uses
Tamsulosin
Gastrointestinal Neoplasms
Adrenergic Antagonists
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009