Prevention of Acute Voiding Difficulty After Radical Proctectomy

NCT00606983 | Completed Phase 3 DMC

• 2 other identifiers: B-0702-042-006SNUBH-GS-CR3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Re-insertion rate of urinary catheter after removal

  after removal of urinary catheter

Secondary Outcomes (1)

• Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry

  at postoperative day 7

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL

oral administration of Tamsulosin

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

oral administration of Tamsulosin

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Surgery, Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34184246 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Urinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Sung-Bum Kang, M.D., Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: May 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

KR (1)