Hernia Surgery Urinary Retention

Overview

Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair.

Full Title of Study: “Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 13, 2020

Detailed Description

The purpose of this study will be to investigate whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair surgery. It is also of interest to determine whether or not a well-known urological screening tool, the IPSS, can identify patients at risk for urinary retention following elective laparoscopic or open hernia repair surgery. We will investigate if it is possible to pre-treat patients with a selective alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative urinary retention and the associated adverse consequences, especially in those patients at higher risk.

Interventions

  • Drug: Tamsulosin
    • Tamsulosin treatment for 7 days pre-operatively

Arms, Groups and Cohorts

  • Experimental: Treatment
    • treatment with a selective alpha1-adrenoceptor antagonist
  • No Intervention: Control
    • no treatment

Clinical Trial Outcome Measures

Primary Measures

  • Post-operative urinary retention
    • Time Frame: 2 weeks
    • Incidence of post-operative urinary retention in patients undergoing hernia repair

Secondary Measures

  • Effect of IPSS
    • Time Frame: 2 weeks
    • the variance in the relationship between treatment arm and incidence of post-operative urinary retention in patients undergoing hernia repair that is attributable to International Prostate Symptom Score (IPSS)

Participating in This Clinical Trial

Inclusion Criteria

  • Male
  • 18 years of age
  • Presenting with hernia requiring surgical intervention

Exclusion Criteria

  • Intolerability of tamsulosin or related drugs
  • Investigator discretion
  • Unwillingness or inability to comply with protocol procedures and assessments

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Health University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Vishu Danthuluri, M.D., 256.665-6214, vishwanathdanthuluri@memorialhealth.com

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