Prevention of Acute Voiding Difficulty After Radical Proctectomy

Rectal Cancer Clinical Trial

Official title:

Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606983
• Other study ID #: B-0702-042-006
• Secondary ID: SNUBH-GS-CR3
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2008
• Last updated: July 18, 2011
• Start date: May 2007
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Urinary Retention

Intervention

Drug:
• Tamsulosin
oral administration of Tamsulosin

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-insertion rate of urinary catheter after removal		after removal of urinary catheter	No
Secondary	Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry		at postoperative day 7	No