Prevention of Acute Voiding Difficulty After Radical Proctectomy

NCT ID: NCT00606983

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-09-30

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.

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.

Conditions

Rectal Cancer; Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

oral administration of Tamsulosin

Group Type: EXPERIMENTAL

Tamsulosin

Intervention Type: DRUG

oral administration of Tamsulosin

Interventions

Tamsulosin

oral administration of Tamsulosin

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of Surgery, Seoul National University Bundang Hospital

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Department of Surgery, Seoul National University Bundang Hospital

Seongnam, , South Korea

Countries

South Korea

References

Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

Reference Type: DERIVED

PMID: 34184246 (View on PubMed)

Other Identifiers

SNUBH-GS-CR3

Identifier Type: -

Identifier Source: secondary_id

B-0702-042-006

Identifier Type: -

Identifier Source: org_study_id