Back to resultsProphylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
Primary Purpose
Post-Operative Urinary Retention
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Education
Sponsored by
About this trial
This is an interventional prevention trial for Post-Operative Urinary Retention focused on measuring Post-Operative Urinary Retention
Eligibility Criteria
Inclusion Criteria:
- Any male age 40 or older
- Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
- Ability to give informed consent
Exclusion Criteria:
- Current use of alpha blocker
- Current use of a strong CYP 3A4 inhibitors
- Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
- Patients with any upcoming surgery for cataracts
- Currently enrolled in a clinical trial
- Inability to give informed consent
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tamsulosin Group
Education Group
Arm Description
Subjects will receive: 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery education about signs and symptoms of urinary retention
Subjects will receive: 1) education about signs and symptoms of urinary retention
Outcomes
Primary Outcome Measures
Number of Participants With Post-operative Urinary Retention
Secondary Outcome Measures
Full Information
NCT ID
NCT02684344
First Posted
February 8, 2016
Last Updated
January 2, 2019
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02684344
Brief Title
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
Official Title
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Urinary Retention
Keywords
Post-Operative Urinary Retention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin Group
Arm Type
Experimental
Arm Description
Subjects will receive:
0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery
education about signs and symptoms of urinary retention
Arm Title
Education Group
Arm Type
Active Comparator
Arm Description
Subjects will receive:
1) education about signs and symptoms of urinary retention
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Flomax
Intervention Description
Tamsulosin may have prophylactic properties against post-operative urinary retention
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Education about signs and symptoms of urinary retention
Primary Outcome Measure Information:
Title
Number of Participants With Post-operative Urinary Retention
Time Frame
5 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any male age 40 or older
Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
Ability to give informed consent
Exclusion Criteria:
Current use of alpha blocker
Current use of a strong CYP 3A4 inhibitors
Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
Patients with any upcoming surgery for cataracts
Currently enrolled in a clinical trial
Inability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward E. Messing, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
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