Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair

Overview

Double blinded, randomized controlled prospective study looking at 2 preoperative doses of Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention. A previous study was conducted called "Effectiveness of tamsulosin inprevention of postoperative urinary retention: a randomized double-blind-placebo controlled study" This study involved a tertiary care center involving mostly urological surgical procedures. We look to specifically look at inguinal hernia surgeries in males. The aim of this study is to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention. The drug is FDA approved for benign prostatic hypertrophy and urinary retention. It is on formulary at Genesys. Currently there is no standard procedure of prophylactic tamsulosin for urinary retention. Most often post operative patients are given tamsulosin to augment smooth muscle relaxation and spontaneous voiding if the patient is having urinary retention post operatively. We often straight catheterize patients once and start tamsulosin with the goal of avoiding urinary retention and future straight catheterizations or placement of foley catheters

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 30, 2018

Interventions

  • Drug: Tamsulosin
  • Drug: Placebo Oral Capsule

Arms, Groups and Cohorts

  • Experimental: A
    • Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.
  • Placebo Comparator: B
    • Placebo medication given the night before surgery and another dose the day of surgery in the morning

Clinical Trial Outcome Measures

Primary Measures

  • number of Urinary Retention
    • Time Frame: within 72 hours of surgery
    • If patients have urinary retention post operatively

Secondary Measures

  • placebo vs tamsulosin
    • Time Frame: within 72 hours of surgery

Participating in This Clinical Trial

Inclusion Criteria

  • healthy males, who are not taking Tamsulosin regularly who are undergoing elective inguinal hernia repair (laparoscopic, open, and robotic assisted) Exclusion Criteria:

  • Patients who are already taking tamsulosin, terazosin (alpha blocker treatement for BPH) , finasteride, dutasteride ( both 5 alpha reductase inhibitors), sulfa allergy, and lactose allergy

Gender Eligibility: Male

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ascension Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anthony Tabatabai, General Surgery Resident – Ascension Health

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