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Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Indwelling urethral catheterization (Foley)
Clean intermittent catheterization (CIC)
Foley
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring Urethral catheter, clean intermittent catheterization, UTI, pain, quality of life, hematuria, cloudy urine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015.

Exclusion Criteria:

  • Patients under 18 years of age
  • History of urinary retention
  • Urinary tract infection
  • Poor compliance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Indwelling urethral catheterization (Foley)

    Clean intermittent catheterization (CIC)

    Arm Description

    Foley catheter as the intervention.

    CIC as the intervention .

    Outcomes

    Primary Outcome Measures

    Catheter-associated urinary tract infection (CAUTI)
    the presence of symptoms or signs compatible with UTI and no other identified source of infection, along with ≥103 CFU/mL of ≥1 bacterial species in a single catheter urine specimen or in a midstream voided urine specimen from a patient whose urethral catheter has been removed within the previous 48 hours.

    Secondary Outcome Measures

    Pain
    Using visual analogue scales
    Hematuria
    Cloudy urine
    Quality of life
    assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire
    Catheter-associated asymptomatic bacteriuria
    the presence of ≥105 CFU/mL of ≥1 bacterial species in a single catheter urine specimen from a patient without symptoms compatible with UTI.

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    October 21, 2016
    Sponsor
    Ramathibodi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02942641
    Brief Title
    Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention
    Official Title
    Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention: A Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: Acute urinary retention (AUR) is a common problem in hospitalized patients. Either indwelling urethral catheterization or clean intermittent catheterization (CIC) can be the choice of treatment. In chronic urinary retention, most physicians prefer CIC to chronic indwelling urethral catheter on the basis of the claim that the rate of catheter-associated urinary tract infection (CAUTI) is lower. Method: The patients were randomized into indwelling urethral catheter and CIC groups. The primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI. The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.
    Detailed Description
    We queried the hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015. Patients under 18 years of age with a history of urinary retention, urinary tract infection, and poor compliance were excluded from this study. All the patients gave their written informed consents. The patients were randomly divided into two groups depending on the type of assigned intervention: CIC and indwelling urethral catheter groups. All the patients were followed up after 2 weeks; urinalysis and urine culture were obtained at the time of AUR and whenever the patients developed UTI-associated symptoms. The patients with positive urine culture at the time of AUR were excluded from the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Retention
    Keywords
    Urethral catheter, clean intermittent catheterization, UTI, pain, quality of life, hematuria, cloudy urine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Indwelling urethral catheterization (Foley)
    Arm Type
    Experimental
    Arm Description
    Foley catheter as the intervention.
    Arm Title
    Clean intermittent catheterization (CIC)
    Arm Type
    Experimental
    Arm Description
    CIC as the intervention .
    Intervention Type
    Procedure
    Intervention Name(s)
    Indwelling urethral catheterization (Foley)
    Intervention Description
    Hospitalized patients who developed first-time AUR were randomly divided into two groups depending on the type of assigned intervention: CIC and indwelling urethral catheter groups. Patients in this group received indwelling urethral catheter as the intervention.
    Intervention Type
    Procedure
    Intervention Name(s)
    Clean intermittent catheterization (CIC)
    Intervention Description
    Hospitalized patients who developed first-time AUR were randomly divided into two groups depending on the type of assigned intervention: CIC and indwelling urethral catheter groups. Patients in this group received CIC as the intervention.
    Intervention Type
    Device
    Intervention Name(s)
    Foley
    Primary Outcome Measure Information:
    Title
    Catheter-associated urinary tract infection (CAUTI)
    Description
    the presence of symptoms or signs compatible with UTI and no other identified source of infection, along with ≥103 CFU/mL of ≥1 bacterial species in a single catheter urine specimen or in a midstream voided urine specimen from a patient whose urethral catheter has been removed within the previous 48 hours.
    Time Frame
    up to 12 months
    Secondary Outcome Measure Information:
    Title
    Pain
    Description
    Using visual analogue scales
    Time Frame
    up to 12 months
    Title
    Hematuria
    Time Frame
    up to 12 months
    Title
    Cloudy urine
    Time Frame
    up to 12 months
    Title
    Quality of life
    Description
    assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire
    Time Frame
    up to 12 months
    Title
    Catheter-associated asymptomatic bacteriuria
    Description
    the presence of ≥105 CFU/mL of ≥1 bacterial species in a single catheter urine specimen from a patient without symptoms compatible with UTI.
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015. Exclusion Criteria: Patients under 18 years of age History of urinary retention Urinary tract infection Poor compliance

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention

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