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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01209988
First received: September 27, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported outcomes [ Time Frame: 20 days after surgery (plus or minus 3 days) ] [ Designated as safety issue: No ]

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

  Eligibility

Genders 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
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 ClinicalTrials.gov identifier: NCT01209988

Contacts
Contact: Choung-Soo Kim, M.D. 82-2-3010-3734 ext No 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

No publications provided

Responsible Party: Choung-Soo Kim/professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01209988     History of Changes
Other Study ID Numbers: AMC_UR_010
Study First Received: September 27, 2010
Last Updated: September 27, 2010
Health Authority: Institutional Review Board: Republic of Korea

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014