Urinary RetentionNCT02942641
Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention
A study testing Indwelling urethral catheterization (Foley), Clean intermittent catheterization (CIC) and Foley in people with Urinary Retention, run by Ramathibodi Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Indwelling urethral catheterization (Foley), Clean intermittent catheterization (CIC) and Foley
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015.
Who cannot join
- Patients under 18 years of age
- History of urinary retention
- Urinary tract infection
- Poor compliance
About this study
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
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.
Read the 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.
- Conditions
- Urinary Retention
- Being tested
- Indwelling urethral catheterization (Foley), Clean intermittent catheterization (CIC), Foley
- Keywords
- Urethral catheter, clean intermittent catheterization, UTI, pain, quality of life, hematuria, cloudy urine
- Medical subject headings
- Urinary Retention, Pain, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling urethral catheterization (Foley)Procedure or surgery
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 or surgery
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.
FoleyDevice
| Study group | Role | What they receive |
|---|---|---|
| Indwelling urethral catheterization (Foley) | Experimental | Foley catheter as the intervention. Receives: Procedure: Indwelling urethral catheterization (Foley); Device: Foley |
| Clean intermittent catheterization (CIC) | Experimental | CIC as the intervention . Receives: Procedure: Clean intermittent catheterization (CIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (5)
Pain
Using visual analogue scales
Measured: up to 12 months
Hematuria
Measured: up to 12 months
Cloudy urine
Measured: up to 12 months
Quality of life
assessed on the basis of social functioning (SF) that was derived from SF-36 questionnaire
Measured: 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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pocharapong Jenjitranant, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942641
- Sponsor's protocol ID
- 095920
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02942641
- Acronym / sponsor ID
- 095920
- Conditions
- Urinary Retention
- Keywords
- Urethral catheter, clean intermittent catheterization, UTI, pain, quality of life, hematuria, cloudy urine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indwelling urethral catheterization (Foley) | Experimental | Procedure: Indwelling urethral catheterization (Foley), Device: FoleyFoley catheter as the intervention. |
| Clean intermittent catheterization (CIC) | Experimental | Procedure: Clean intermittent catheterization (CIC)CIC as the intervention . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015.
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- History of urinary retention
- Urinary tract infection
- Poor compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Indwelling urethral catheterization (Foley) |
| 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. | Procedure or surgery | Clean intermittent catheterization (CIC) |
| Foley | Device | Indwelling urethral catheterization (Foley) |
Primary outcome
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.
5 secondary outcomes
Pain
Time frame: up to 12 months
Hematuria
Time frame: up to 12 months
Cloudy urine
Time frame: up to 12 months
Quality of life
Time frame: up to 12 months
Catheter-associated asymptomatic bacteriuria
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Indwelling urethral catheterization (Foley), Clean intermittent catheterization (CIC) and Foley in people with Urinary Retention, run by Ramathibodi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter-associated urinary tract infection (CAUTI) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016; AzTrials last refreshed its copy on 26 Oct 2026.