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

Urinary Retention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942641
• Other study ID #: 095920
• Status: Completed
• Phase: N/A
• First received: October 19, 2016
• Last updated: October 21, 2016
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Procedure:
• Indwelling urethral catheterization (Foley)
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.
• Clean intermittent catheterization (CIC)
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.

Device:
• Foley

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pain	Using visual analogue scales	up to 12 months	Yes
Secondary	Hematuria		up to 12 months	Yes
Secondary	Cloudy urine		up to 12 months	Yes
Secondary	Quality of life	assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire	up to 12 months	Yes
Secondary	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	Yes