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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention: A Prospective Randomized Trial

Conditions
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Urinary Retention

Intervention / Treatment
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* Procedure: Indwelling urethral catheterization (Foley)
* Procedure: Clean intermittent catheterization (CIC)
* Device: Foley


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indwelling urethral catheterization (Foley)<br>Foley catheter as the intervention. | Procedure: Indwelling urethral catheterization (Foley)<br>* 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.<br>Device: Foley<br> <br> |
| Experimental: Clean intermittent catheterization (CIC)<br>CIC as the intervention . | Procedure: Clean intermittent catheterization (CIC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Using visual analogue scales | up to 12 months | 
| Hematuria |  | up to 12 months | 
| Cloudy urine |  | up to 12 months | 
| Quality of life | assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire | up to 12 months | 
| 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. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urethral catheter, clean intermittent catheterization, UTI, pain, quality of life, hematuria, cloudy urine