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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.