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

Primary Purpose

Postoperative Urinary Retention

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tamsulosin
Placebo Oral Capsule
Sponsored by
Ascension Genesys Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Urinary Retention

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    A

    B

    Arm Description

    Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.

    Placebo medication given the night before surgery and another dose the day of surgery in the morning

    Outcomes

    Primary Outcome Measures

    number of Urinary Retention
    If patients have urinary retention post operatively

    Secondary Outcome Measures

    placebo vs tamsulosin

    Full Information

    First Posted
    November 5, 2016
    Last Updated
    July 29, 2019
    Sponsor
    Ascension Genesys Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02958878
    Brief Title
    Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair
    Official Title
    Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2017 (Actual)
    Primary Completion Date
    November 30, 2018 (Actual)
    Study Completion Date
    November 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ascension Genesys Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Urinary Retention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.
    Arm Title
    B
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo medication given the night before surgery and another dose the day of surgery in the morning
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin
    Other Intervention Name(s)
    Flomax
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Oral Capsule
    Primary Outcome Measure Information:
    Title
    number of Urinary Retention
    Description
    If patients have urinary retention post operatively
    Time Frame
    within 72 hours of surgery
    Secondary Outcome Measure Information:
    Title
    placebo vs tamsulosin
    Time Frame
    within 72 hours of surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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