Prevention of Acute Voiding Difficulty After Radical Proctectomy
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ClinicalTrials.gov Identifier: NCT00606983 |
Recruitment Status :
Completed
First Posted : February 5, 2008
Last Update Posted : July 20, 2011
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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 |
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 Type : | Interventional (Clinical Trial) |
Estimated 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 2007 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
No Intervention: 1 | |
Experimental: 2
oral administration of Tamsulosin
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Drug: Tamsulosin
oral administration of Tamsulosin |
- Re-insertion rate of urinary catheter after removal [ Time Frame: after removal of urinary catheter ]
- Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry [ Time Frame: at postoperative day 7 ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606983
Korea, Republic of | |
Department of Surgery, Seoul National University Bundang Hospital | |
Seongnam, Korea, Republic of, 463-707 |
Principal Investigator: | Sung-Bum Kang, M.D., Ph.D | Seoul National University Bundang Hospital |
Responsible Party: | Sung-Bum Kang, Department of Surgery, Seoul National University Bundang Hospital |
ClinicalTrials.gov Identifier: | NCT00606983 |
Other Study ID Numbers: |
B-0702-042-006 SNUBH-GS-CR3 |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | July 20, 2011 |
Last Verified: | July 2011 |
Rectal Neoplasms Urinary Retention 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 Tamsulosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |