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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Asan Medical Center.
Recruitment status was:  Recruiting
Astellas Pharma Inc
Information provided by:
Asan Medical Center Identifier:
First received: September 27, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
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 Intervention
Prostatic Neoplasms, Prostatectomy Drug: tamsulosin 0.4mg Other: No medication

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

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

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

Estimated Enrollment: 220
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01209988

Contact: Choung-Soo Kim, M.D. 82-2-3010-3734

Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Choung-Soo Kim, M.D.   
Sponsors and Collaborators
Asan Medical Center
Astellas Pharma Inc
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 Identifier: NCT01209988     History of Changes
Other Study ID Numbers: AMC_UR_010
Study First Received: September 27, 2010
Last Updated: September 27, 2010

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
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 processed this record on September 21, 2017