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

September 27, 2010 updated by: Asan Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamsulosin 0.4mg
Perioperative tamsulosin 0.4mg daily
Drug: tamsulosin 0.4mg
perioperative tamsulosin 0.4mg daily for three weeks
Placebo Comparator: Control
No medication
Other: No medication
No medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of acute urinary retention
Time Frame: within the 30 days after surgery
within the 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient reported outcomes
Time Frame: 20 days after surgery (plus or minus 3 days)
20 days after surgery (plus or minus 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Choung-Soo Kim, M.D., Department of Urology, Asan Medical Center, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

September 28, 2010

Last Update Submitted That Met QC Criteria

September 27, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC_UR_010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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