Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedOctober 24, 2016
October 1, 2016
11 months
October 19, 2016
October 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Pain
up to 12 months
Hematuria
up to 12 months
Cloudy urine
up to 12 months
Quality of life
up to 12 months
Catheter-associated asymptomatic bacteriuria
up to 12 months
Study Arms (2)
Indwelling urethral catheterization (Foley)
EXPERIMENTALFoley catheter as the intervention.
Clean intermittent catheterization (CIC)
EXPERIMENTALCIC as the intervention .
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015.
You may not qualify if:
- Patients under 18 years of age
- History of urinary retention
- Urinary tract infection
- Poor compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Pocharapong Jenjitranant
Study Record Dates
First Submitted
October 19, 2016
First Posted
October 24, 2016
Study Start
June 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 24, 2016
Record last verified: 2016-10