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Hernia Surgery Urinary Retention

Sponsor
Memorial Health University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03027115
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
36.4
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization to 1 of 2 possible arms, control and treatmentRandomization to 1 of 2 possible arms, control and treatment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment
Actual Study Start Date :
Jan 13, 2017
Anticipated Primary Completion Date :
Jan 13, 2020
Anticipated Study Completion Date :
Jan 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

treatment with a selective alpha1-adrenoceptor antagonist

Drug: Tamsulosin
Tamsulosin treatment for 7 days pre-operatively
Other Names:
  • Flomax

    		•
    No Intervention: Control

    no treatment

    Outcome Measures

    Primary Outcome Measures

    1. Post-operative urinary retention [2 weeks]

      Incidence of post-operative urinary retention in patients undergoing hernia repair

    Secondary Outcome Measures

    1. Effect of IPSS [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Health University Medical Center Savannah Georgia United States 31404

    Sponsors and Collaborators

    • Memorial Health University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Memorial Health University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03027115
    Other Study ID Numbers:
    • MHUMC 2016.10.05
    First Posted:
    Jan 20, 2017
    Last Update Posted:
    Mar 23, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Urinary Retention
    Hernia
    Tamsulosin

    Study Results

    No Results Posted as of Mar 23, 2018