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

Not Applicable

• Conditions: Prostatic Neoplasms, Prostatectomy
• Interventions: Drug: tamsulosin 0.4mg; Other: No medication

• Registration Number: NCT01209988
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-09
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Last Update Submitted: 2010-09-27
• Study First Posted: 2010-09-28
• Last Update Posted: 2010-09-28
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin 0.4mg	tamsulosin 0.4mg	Perioperative tamsulosin 0.4mg daily
Control	No medication	No medication

Primary Outcome Measures

Name	Time	Method
The incidence of acute urinary retention	within the 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes	20 days after surgery (plus or minus 3 days)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of