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

Not Applicable

Completed

• Conditions: Urinary Retention
• Interventions: Procedure: Indwelling urethral catheterization (Foley); Procedure: Clean intermittent catheterization (CIC); Device: Foley

• Registration Number: NCT02942641
• Lead Sponsor: Ramathibodi Hospital

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-21
• Last Update Submitted: 2016-10-21
• Study First Posted: 2016-10-24
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indwelling urethral catheterization (Foley)	Indwelling urethral catheterization (Foley)	Foley catheter as the intervention.
Clean intermittent catheterization (CIC)	Clean intermittent catheterization (CIC)	CIC as the intervention .
Indwelling urethral catheterization (Foley)	Foley	Foley catheter as the intervention.

Primary Outcome Measures

Name	Time	Method
Catheter-associated urinary tract infection (CAUTI)	up to 12 months	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

Name	Time	Method
Cloudy urine	up to 12 months
Quality of life	up to 12 months	assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire
Hematuria	up to 12 months
Catheter-associated asymptomatic bacteriuria	up to 12 months	the presence of ≥105 CFU/mL of ≥1 bacterial species in a single catheter urine specimen from a patient without symptoms compatible with UTI.
Pain	up to 12 months	Using visual analogue scales