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Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT01209988
Recruitment Status : Unknown
Verified September 2010 by Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 28, 2010
Last Update Posted : September 28, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.

Condition or disease Intervention/treatment
Prostatic Neoplasms, Prostatectomy Drug: tamsulosin 0.4mg Other: No medication

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
Study Start Date : April 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Tamsulosin 0.4mg
Perioperative tamsulosin 0.4mg daily
Drug: tamsulosin 0.4mg
perioperative tamsulosin 0.4mg daily for three weeks
Placebo Comparator: Control
No medication
Other: No medication
No medication


Outcome Measures

Primary Outcome Measures :
  1. The incidence of acute urinary retention [ Time Frame: within the 30 days after surgery ]

Secondary Outcome Measures :
  1. Patient reported outcomes [ Time Frame: 20 days after surgery (plus or minus 3 days) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have localized or locally advanced prostate cancer
  • Patients must receive robot assisted laparoscopic radical prostatectomy
  • Patients must be able to provide written informed consent

Exclusion Criteria:

  • Patients must not have a history of treatment with alpha blockers within 4 weeks
  • Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate
  • Patients must not have previously been diagnosed with neurogenic bladder
  • Patients must not have hypersensitivity to trial drug or other alpha-blockers
  • Patients must not have the participation of other clinical trial within the past 3 months
Contacts and Locations

Information from the National Library of Medicine

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): NCT01209988


Contacts
Contact: Choung-Soo Kim, M.D. 82-2-3010-3734 cskim@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Choung-Soo Kim, M.D.       cskim@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Astellas Pharma Inc
Investigators
Principal Investigator: Choung-Soo Kim, M.D. Department of Urology, Asan Medical Center, Seoul, Korea
More Information

Responsible Party: Choung-Soo Kim/professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01209988     History of Changes
Other Study ID Numbers: AMC_UR_010
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic 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