Urine Leakage in the Indwelling Urinary CatheterizationNCT04103229
Urinary Leakage in the Indwelling Urinary Catheterization
A study testing The use of different types and volumes of solutions to inflate the catheter balloon in people with Urine Leakage in the Indwelling Urinary Catheterization, run by Ayşe AKBIYIK.
Trial summary
In the indwelling urinary catheterization (IUC), urinary leakage may develop around the catheter in the following days of catheterization. The volume and type of fluid used to inflate the catheter balloon has the potential to be a factor in the development of this problem. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urine Leakage in the Indwelling Urinary Catheterization
- What is being tested?
- The use of different types and volumes of solutions to inflate the catheter balloon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 30 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years,
- Patients with indication for IUC (presence of order),
- Patients eligible for the use of a 18 Fr silicone foley catheter,
- Patients who did not have a problem that could affect prostate hypertrophy and/or urinary system miction.
Who cannot join
- In the study, if urine leakage occurred within 12 hours after catheterization, it was assumed that the leakage was caused by the size of the catheter, and these patients/patients were excluded from the study.
About this study
Official title: Investigation of Two Different Types of Solution and Volume for Inflating Foley Catheter Balloon in Indwelling Urinary Catheterization
In the indwelling urinary catheterization (IUC), urinary leakage may develop around the catheter in the following days of catheterization. The volume and type of fluid used to inflate the catheter balloon has the potential to be a factor in the development of this problem.
In this study, the investigators aimed to investigate the effect of the type and amount of fluid used in inflating the silicone foley catheter balloon on the development of urinary leakage around the catheter. In addition to purpose, the following questions were answered to determine the optimal solution type and volume in inflating the balloon:
- What was the incidence of urinary leakage in IUC?
- Was there a relationship between catheterization time and urine leakage?
- Was there a relationship between the type of fluid used to inflate the foley catheter balloon and urine leakage?
- Was there a relationship between the amount of fluid used to inflate the foley catheter balloon and urine leakage?
- Being tested
- The use of different types and volumes of solutions to inflate the catheter balloon
- Keywords
- Urine Leakage, Indwelling urethral catheter, silicone catheter, Saline, Balloon, Distilled water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of different types and volumes of solutions to inflate the catheter balloonProcedure or surgery
In catheterization procedure, catheter balloon was inflated according to the type and amount of fluid appropriate to the group to which the patient was assigned.
| Study group | Role | What they receive |
|---|---|---|
| 10 ml sterile distilled water | Experimental | The indwelling urinary catheterization was inflated with 10 ml sterile distilled water (SDW) of the balloon. Receives: Procedure: The use of different types and volumes of solutions to inflate the catheter balloon |
| 15 ml sterile distilled water | Experimental | The indwelling urinary catheterization was inflated with 15 ml sterile distilled water (SDW) of the balloon. Receives: Procedure: The use of different types and volumes of solutions to inflate the catheter balloon |
| 10 ml 0.9% sodium chloride (NaCL) | Experimental | The indwelling urinary catheterization was inflated with 10 ml 0.9% sodium chloride (NaCL) of the balloon. Receives: Procedure: The use of different types and volumes of solutions to inflate the catheter balloon |
| 15 ml 0.9% sodium chloride (NaCL) | Experimental | The IUC was inflated with 15 ml 0.9% sodium chloride (NaCL) of the balloon. Receives: Procedure: The use of different types and volumes of solutions to inflate the catheter balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of urine leakage around the catheter
Patients were followed up every 12 hours for the presence of urine leakage around the catheter. The presence of urine leakage was monitored by macroscopic examination, wetting of the diaper, and pH meter strip wrapped around the catheter. In addition, urine samples of the urine leakage were collected, and urine pH and leakage pH were compared.
Participation of the patients in the study groups was continued until one or more of the following criteria met:
Urinary leakage around the catheter, Termination of catheterization, Transferring the patient to another unit, Development of Exitus.
Measured: through study completion, about three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Apr 2015
- Primary completion31 Jan 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Leakage in the Indwelling Urinary CatheterizationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe AKBIYIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe AKBIYIK, Izmir Katip Celebi University
- Investigators
- Ayse AKBIYIK, PhD, Principal investigator, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103229
- Sponsor's protocol ID
- EGE.0.20.05.00/OY/784/313
- Status last verified
- Sep 2019
- First submitted
- 22 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Two Different Types of Solution and Volume for Inflating Foley Catheter Balloon in Indwelling Urinary Catheterization
- ClinicalTrials.gov ID
- NCT04103229
- Acronym / sponsor ID
- EGE.0.20.05.00/OY/784/313
- Keywords
- Urine Leakage, Indwelling urethral catheter, silicone catheter, Saline, Balloon, Distilled water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ayşe AKBIYIKUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 25 Sep 2019 (actual)
- 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.
In the indwelling urinary catheterization (IUC), urinary leakage may develop around the catheter in the following days of catheterization. The volume and type of fluid used to inflate the catheter balloon has the potential to be a factor in the development of this problem.
In this study, the investigators aimed to investigate the effect of the type and amount of fluid used in inflating the silicone foley catheter balloon on the development of urinary leakage around the catheter. In addition to purpose, the following questions were answered to determine the optimal solution type and volume in inflating the balloon:
- What was the incidence of urinary leakage in IUC?
- Was there a relationship between catheterization time and urine leakage?
- Was there a relationship between the type of fluid used to inflate the foley catheter balloon and urine leakage?
- Was there a relationship between the amount of fluid used to inflate the foley catheter balloon and urine leakage?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 ml sterile distilled water | Experimental | Procedure: The use of different types and volumes of solutions to inflate the catheter balloonThe indwelling urinary catheterization was inflated with 10 ml sterile distilled water (SDW) of the balloon. |
| 15 ml sterile distilled water | Experimental | Procedure: The use of different types and volumes of solutions to inflate the catheter balloonThe indwelling urinary catheterization was inflated with 15 ml sterile distilled water (SDW) of the balloon. |
| 10 ml 0.9% sodium chloride (NaCL) | Experimental | Procedure: The use of different types and volumes of solutions to inflate the catheter balloonThe indwelling urinary catheterization was inflated with 10 ml 0.9% sodium chloride (NaCL) of the balloon. |
| 15 ml 0.9% sodium chloride (NaCL) | Experimental | Procedure: The use of different types and volumes of solutions to inflate the catheter balloonThe IUC was inflated with 15 ml 0.9% sodium chloride (NaCL) of the balloon. |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18 years,
- Patients with indication for IUC (presence of order),
- Patients eligible for the use of a 18 Fr silicone foley catheter,
- Patients who did not have a problem that could affect prostate hypertrophy and/or urinary system miction.
Key exclusion criteria (1 listed)
- In the study, if urine leakage occurred within 12 hours after catheterization, it was assumed that the leakage was caused by the size of the catheter, and these patients/patients were excluded from the study.
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 |
|---|---|---|
| The use of different types and volumes of solutions to inflate the catheter balloonIn catheterization procedure, catheter balloon was inflated according to the type and amount of fluid appropriate to the group to which the patient was assigned. | Procedure or surgery | 10 ml 0.9% sodium chloride (NaCL), 10 ml sterile distilled water, 15 ml 0.9% sodium chloride (NaCL), 15 ml sterile distilled water |
Primary outcome
Development of urine leakage around the catheter
Time frame: through study completion, about three years
Patients were followed up every 12 hours for the presence of urine leakage around the catheter. The presence of urine leakage was monitored by macroscopic examination, wetting of the diaper, and pH meter strip wrapped around the catheter. In addition, urine samples of the urine leakage were collected, and urine pH and leakage pH were compared. Participation of the patients in the study groups was continued until one or more of the following criteria met: Urinary leakage around the catheter, Termination of catheterization, Transferring the patient to another unit, Development of Exitus.
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 25 Sep 2019.
- Individual participant dataSharing planned: No
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.
Ayse AKBIYIK, PhD principal investigator
İzmir Katip Çelebi University
Questions about this trial
What is this clinical trial studying?
A study testing The use of different types and volumes of solutions to inflate the catheter balloon in people with Urine Leakage in the Indwelling Urinary Catheterization, run by Ayşe AKBIYIK.
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 4 inclusion and 1 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 25 Sep 2019. 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?
Development of urine leakage around the catheter (time frame: through study completion, about three years). 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 25 Sep 2019.