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Prevention of Acute Voiding Difficulty After Radical Proctectomy

Primary Purpose

Rectal Cancer, Urinary Retention

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Surgery, Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

oral administration of Tamsulosin

Outcomes

Primary Outcome Measures

Re-insertion rate of urinary catheter after removal

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2008
Last Updated
July 18, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00606983
Brief Title
Prevention of Acute Voiding Difficulty After Radical Proctectomy
Official Title
Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
oral administration of Tamsulosin
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
oral administration of Tamsulosin
Primary Outcome Measure Information:
Title
Re-insertion rate of urinary catheter after removal
Time Frame
after removal of urinary catheter
Secondary Outcome Measure Information:
Title
Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry
Time Frame
at postoperative day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Bum Kang, M.D., Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34184246
Citation
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.
Results Reference
derived

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Prevention of Acute Voiding Difficulty After Radical Proctectomy

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