Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

Not Applicable

Terminated

• Conditions: Post-Operative Urinary Retention
• Interventions: Drug: Tamsulosin; Other: Education

• Registration Number: NCT02684344
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-15
• Study First Posted: 2016-02-18
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-01
• Results First Submitted: 2019-01-02
• Results First Submitted QC: 2019-01-02
• Last Update Submitted: 2019-01-02
• Results First Posted: 2019-01-23
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin Group	Education	Subjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention
Education Group	Education	Subjects will receive: 1) education about signs and symptoms of urinary retention
Tamsulosin Group	Tamsulosin	Subjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention

Primary Outcome Measures

Name	Time	Method
Number of Participants With Post-operative Urinary Retention	5 days

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States