Skip to main content
OpenTrials
Completed

NCT Number: NCT02942641

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematuria Hemorrhage Male Urogenital Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indwelling urethral catheterization (Foley)

Procedure

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)

Procedure

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.

Foley

Device

Primary outcomes

  1. Catheter-associated urinary tract infection (CAUTI)

    Time frame: 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 outcomes

  1. Pain

    Time frame: up to 12 months

    Using visual analogue scales

  2. Hematuria

    Time frame: up to 12 months

  3. Cloudy urine

    Time frame: up to 12 months

  4. Quality of life

    Time frame: up to 12 months

    assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire

  5. Catheter-associated asymptomatic bacteriuria

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2016
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.