Prostatic Neoplasms, Prostatectomy Clinical Trial
Official title:
A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center | Astellas Pharma Inc |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of acute urinary retention | within the 30 days after surgery | No | |
Secondary | Patient reported outcomes | 20 days after surgery (plus or minus 3 days) | No |