Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy
A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 27, 2010
CompletedFirst Posted
Study publicly available on registry
September 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 28, 2010
September 1, 2010
1.7 years
September 27, 2010
September 27, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of acute urinary retention
within the 30 days after surgery
Secondary Outcomes (1)
Patient reported outcomes
20 days after surgery (plus or minus 3 days)
Study Arms (2)
Tamsulosin 0.4mg
EXPERIMENTALPerioperative tamsulosin 0.4mg daily
Control
PLACEBO COMPARATORNo medication
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Astellas Pharma Inccollaborator
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Choung-Soo Kim, M.D.
Department of Urology, Asan Medical Center, Seoul, Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 27, 2010
First Posted
September 28, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
September 28, 2010
Record last verified: 2010-09