Prostatic Neoplasms, Prostatectomy
Conditions
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.
Interventions
DRUGtamsulosin 0.4mg
perioperative tamsulosin 0.4mg daily for three weeks
OTHERNo medication
No medication
Sponsors
Astellas Pharma Inc
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of acute urinary retention | within the 30 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported outcomes | 20 days after surgery (plus or minus 3 days) |
Countries
South Korea
Contacts
Primary ContactChoung-Soo Kim, M.D.
Outcome results
None listed