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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01209988
• Other study ID #: AMC_UR_010
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2010
• Last updated: September 27, 2010
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: Asan Medical Center
• Contact: Choung-Soo Kim, M.D.
• Phone: 82-2-3010-3734
• Email: cskim[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Institutional Review Board: Republic of Korea
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Prostatectomy

Intervention

Drug:
• tamsulosin 0.4mg
perioperative tamsulosin 0.4mg daily for three weeks

Other:
• No medication
No medication

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Astellas Pharma Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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