Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Interventions

  • Drug: Tamsulosin
    • Tamsulosin may have prophylactic properties against post-operative urinary retention
  • Other: Education
    • Education about signs and symptoms of urinary retention

Arms, Groups and Cohorts

  • Experimental: Tamsulosin Group
    • 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
  • Active Comparator: Education Group
    • Subjects will receive: 1) education about signs and symptoms of urinary retention

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Post-operative Urinary Retention
    • Time Frame: 5 days

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Rochester
  • Provider of Information About this Clinical Study
    • Principal Investigator: Edward Messing, Principal Investigator – University of Rochester
  • Overall Official(s)
    • Edward E. Messing, MD, Principal Investigator, University of Rochester

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