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
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
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
NCT ID
NCT02942641
First Posted
October 19, 2016
Last Updated
October 21, 2016
Sponsor
Ramathibodi Hospital
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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