Prevention of Acute Voiding Difficulty After Radical Proctectomy

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00606983

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer Urinary Retention	Drug: Tamsulosin	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1
Experimental: 2 oral administration of Tamsulosin	Drug: Tamsulosin oral administration of Tamsulosin

Arm

Intervention/Treatment

No Intervention: 1

Experimental: 2

oral administration of Tamsulosin

Drug: Tamsulosin

oral administration of Tamsulosin

Outcome Measures

Primary Outcome Measures

Re-insertion rate of urinary catheter after removal [after removal of urinary catheter]

Secondary Outcome Measures

Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry [at postoperative day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00606983

Other Study ID Numbers:

B-0702-042-006
SNUBH-GS-CR3

First Posted:

Feb 5, 2008

Last Update Posted:

Jul 20, 2011

Last Verified:

Jul 1, 2011

Additional relevant MeSH terms:

Rectal Neoplasms

Urinary Retention

Tamsulosin

Study Results

No Results Posted as of Jul 20, 2011