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

Primary Purpose

Prostatic Neoplasms, Prostatectomy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tamsulosin 0.4mg
No medication
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms, Prostatectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tamsulosin 0.4mg

Control

Arm Description

Perioperative tamsulosin 0.4mg daily

No medication

Outcomes

Primary Outcome Measures

The incidence of acute urinary retention

Secondary Outcome Measures

Patient reported outcomes

Full Information

First Posted
September 27, 2010
Last Updated
September 27, 2010
Sponsor
Asan Medical Center
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01209988
Brief Title
Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy
Official Title
A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Asan Medical Center
Collaborators
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin 0.4mg
Arm Type
Experimental
Arm Description
Perioperative tamsulosin 0.4mg daily
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No medication
Intervention Type
Drug
Intervention Name(s)
tamsulosin 0.4mg
Intervention Description
perioperative tamsulosin 0.4mg daily for three weeks
Intervention Type
Other
Intervention Name(s)
No medication
Intervention Description
No medication
Primary Outcome Measure Information:
Title
The incidence of acute urinary retention
Time Frame
within the 30 days after surgery
Secondary Outcome Measure Information:
Title
Patient reported outcomes
Time Frame
20 days after surgery (plus or minus 3 days)

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Choung-Soo Kim, M.D.
Phone
82-2-3010-3734
Email
cskim@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choung-Soo Kim, M.D.
Organizational Affiliation
Department of Urology, Asan Medical Center, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Choung-Soo Kim, M.D.
Email
cskim@amc.seoul.kr

12. IPD Sharing Statement

Learn more about this trial

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

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