Urinary Tract InfectionsNCT06265142
Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children
A study testing Bladder catheterization and clean catch urine via bladder massage technique in people with Urinary Tract Infections, run by Oman Medical Speciality Board.
Trial summary
Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral… Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Bladder catheterization and clean catch urine via bladder massage technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 1 Dec 2024
- 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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemodynamically stable infants.
- Require urine collection as part of their work-up in the emergency department.
- Age 0 to 6 months.
Who cannot join
- Parental refusal.
- Unstable hemodynamically young infants.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children: Randomized Control Trial
Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.
Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.
Read more
Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.
Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.
Patient Population: young infants from 0 to 6 months of age
Intervention: There will be two groups:
- Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
- Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.
Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.
Outcome: Contamination rate and feasibility of both urine sampling techniques
Read the detailed description
Urinary tract infection (UTI) is a common source of infection in children. It accounts for 5 to 14 percent of visits by children every year. The overall prevalence is around 7% among different age subgroups of children. Several factors affect the prevalence of UTI including age, gender, and circumcision status.
The diagnosis of UTI requires obtaining a urine specimen from the patient. Generally, there are four methods used in collecting urine samples which can be categorized as invasive (such as suprapubic aspiration and urethral bladder catheterization) and noninvasive (such as Sterile bag and clean catch).
The selection of the urine collection technique is mainly determined by whether the patient is toilet-trained or not. In non-toilet-trained patients, urethral bladder catheterization or suprapubic aspiration can be used. The latter is having the least contamination rate in urine culture. Clean-catch urine is commonly used for toilet-trained patients. If the clinical assessment of febrile infants necessitates immediate antimicrobial therapy, urine culture should be obtained either by urethral bladder catheterization or suprapubic aspiration.
Previous observational studies showed approximately a 1 percent contamination rate using the suprapubic aspiration technique. In a prospective study done on premature infants it was found that the suprapubic aspiration technique resulted in increased pain and a higher probability of procedural failure compared to urethral bladder catheterization. According to American academy of pediatrics (AAP), for non-toilet trained children, it's advisable to gather a urine sample through methods like ureteral catheterization or suprapubic bladder aspiration, especially when a sample obtained using a perineal bag shows positive results on a dipstick test. The latest guideline from AAP recommends urine culture to be obtained via either SPA or bladder catheterization in pediatric patients aged between 8 to 60 days old, due to false positive results that can occur in the other urine collection techniques.
Urethral bladder catheterization carries a 6 to 12 percent of contamination rate. In regard clean catch urine method 16 to 63 percent of the contamination rate.
As outlined in the guideline in National Institute for Health and Care Excellence (NICE) guideline, to use clean catch urine wherever possible in pediatric patients below 16 years old. And to reserve bladder catheterization and suprapubic aspiration when noninvasive methods are not possible or practical.
previous literature demonstrated a safe and noninvasive technique to collect midstream clean-catch urine in infants. It was based on bladder stimulation and paravertebral lumbar massage. This technique yielded accurate and low contamination rates for infants below 90 days old. Moreover, the success rate was 86.3 percent, while the contamination rate was 5 percent. The safety and efficacy of the same stimulation technique in a neonatal intensive care unit setting were described in the literature. The median time to collect urine was 64 seconds. The success rate is 90 percent. However, some literature showed a lower success rate reaching 61 percent, possibly due to patients with a low oral intake that were not excluded from the study.
In the effort to reduce bladder catheterization in children, different techniques were introduced in the previous literature to improve the clean catch urine success rate as well as the contamination rate. Bladder and lumbar paravertebral massage maneuvers are a safe, time-saving technique that needs to be studied further.
In our setting, the recommendations from international guidelines are being followed. For non-toilet trained children suspected to have UTI, initial urine specimen for urine dipstick is collected by sterile bag or bladder catheterization. If the result of the urine dipstick came positive, then urine culture is obtained via bladder catheterization, if the initial specimen collected by the sterile bag. In addition, we lack the statistics of urine culture contamination in our laboratories.
The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.
- Conditions
- Urinary Tract Infections
- Being tested
- Bladder catheterization, clean catch urine via bladder massage technique
- Keywords
- clean catch urine, bladder massage, bladder catheterization, contamination rate
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder catheterizationProcedure or surgery
Participant will undergo the standard bladder catheterization for urine collection
clean catch urine via bladder massage techniqueProcedure or surgery
Participant will undergo clean catch urine via bladder massage technique
| Study group | Role | What they receive |
|---|---|---|
| Catheterization | Other | Group A: is the control group, participant will undergo bladder catheterization. (The standard practice) Receives: Procedure: Bladder catheterization |
| Clean Catch | Experimental | Group B: is the experimental group, participant will undergo clean catch urine via bladder massage technique. Receives: Procedure: clean catch urine via bladder massage technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine culture contamination rate
Urine culture contamination rate will be evaluated in both techniques used in the study which includes dividing the total number of contaminated urine culture sets by the total number of urine culture.
Measured: After urine culture report (usually 2-3 days after urine collection)
Parental satisfaction questionnaire
Parental satisfaction with the procedure techniques (in both arms) will be evaluated by a questionnaire.
Measured: After the procedure immediately
Secondary outcomes (2)
duration of the procedure
duration of the procedure in both arms (in seconds)
Measured: during each procedure
Pain score
Pain score will be assessed by using Neonatal Infant Pain Scale (NIPS), values can range from 0 to 7. NIPS score interpretation 0-1: no pain; 2: mild pain; 3-4: moderate pain; 5-7: severe pain
Measured: after the procedure immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be assessed in triage and cases to be included in the study as per the inclusion criteria, after that patients will be randomized using computerized block randomization technique into two groups. Then, patients will be assigned to a bed, pulse oximetry to be applied, data collection sheet to be filled, confirm that infant had good feeding/ didn't pass urine over last 20 minutes and proper cleaning to be done. The next step will be, collecting urine sample according to randomization group. Group A patients (control group), urine to be collected by standardized catheterization technique while group B by standard CCU technique. Meanwhile, time of each procedure to be documented. Regarding group B , after collecting urine by CCU , we recommend to collect another sample by catheterization to guide the management and antibiotic choice.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sulayyem Saleh Al Harsousi, Oman Medical Speciality Board
- Investigators
- Lubna M Al Lawati, MD, Study director, Oman Medical Speciality Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265142
- Sponsor's protocol ID
- MoH/CSR/23/26368
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still undecided, as it is a pilot study. in the next main study, the IPD will be available.
Publications
Shaikh N, Morone NE, Bost JE, Farrell MH. Prevalence of urinary tract infection in childhood: a meta-analysis. Pediatr Infect Dis J. 2008 Apr;27(4):302-8. doi: 10.1097/INF.0b013e31815e4122.
PubMed 18316994Nader, S. and Alejandro, H., 2021. Urinary tract infections in children: Epidemiology and risk factors. UpToDate, Waltham, MA, pp.1-19. (Accessed on January 01, 2023).
Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management; Roberts KB. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011 Sep;128(3):595-610. doi: 10.1542/peds.2011-1330. Epub 2011 Aug 28.
PubMed 21873693Schroeder AR, Newman TB, Wasserman RC, Finch SA, Pantell RH. Choice of urine collection methods for the diagnosis of urinary tract infection in young, febrile infants. Arch Pediatr Adolesc Med. 2005 Oct;159(10):915-22. doi: 10.1001/archpedi.159.10.915.
PubMed 16203935Tosif S, Baker A, Oakley E, Donath S, Babl FE. Contamination rates of different urine collection methods for the diagnosis of urinary tract infections in young children: an observational cohort study. J Paediatr Child Health. 2012 Aug;48(8):659-64. doi: 10.1111/j.1440-1754.2012.02449.x. Epub 2012 Apr 27.
PubMed 22537082Labrosse M, Levy A, Autmizguine J, Gravel J. Evaluation of a New Strategy for Clean-Catch Urine in Infants. Pediatrics. 2016 Sep;138(3):e20160573. doi: 10.1542/peds.2016-0573. Epub 2016 Aug 19.
PubMed 27542848Al-Orifi F, McGillivray D, Tange S, Kramer MS. Urine culture from bag specimens in young children: are the risks too high? J Pediatr. 2000 Aug;137(2):221-6. doi: 10.1067/mpd.2000.107466.
PubMed 10931415Bogie AL, Sparkman A, Anderson M, Crittenden-Byers C, Barron M. Is There a Difference in the Contamination Rates of Urine Samples Obtained by Bladder Catheterization and Clean-Catch Collection in Preschool Children? Pediatr Emerg Care. 2021 Dec 1;37(12):e788-e790. doi: 10.1097/PEC.0000000000002578.
PubMed 34772880Ballouhey Q, Fourcade L, Couve-Deacon E, Cros J, Lescure V, Bahans C, Chainier D, Garnier F, Guigonis V. Urine Contamination in Nontoilet-trained and Uncircumcised Boys. Urology. 2016 Sep;95:171-4. doi: 10.1016/j.urology.2016.05.056. Epub 2016 Jun 8.
PubMed 27289027Badiee Z, Sadeghnia A, Zarean N. Suprapubic Bladder Aspiration or Urethral Catheterization: Which is More Painful in Uncircumcised Male Newborns? Int J Prev Med. 2014 Sep;5(9):1125-30.
PubMed 25317295Mattoo TK, Shaikh N, Nelson CP. Contemporary Management of Urinary Tract Infection in Children. Pediatrics. 2021 Feb;147(2):e2020012138. doi: 10.1542/peds.2020-012138.
PubMed 33479164Pantell RH, Roberts KB, Adams WG, Dreyer BP, Kuppermann N, O'Leary ST, Okechukwu K, Woods CR Jr; SUBCOMMITTEE ON FEBRILE INFANTS. Evaluation and Management of Well-Appearing Febrile Infants 8 to 60 Days Old. Pediatrics. 2021 Aug;148(2):e2021052228. doi: 10.1542/peds.2021-052228. Epub 2021 Jul 19.
PubMed 34281996National Institute for Health and Care Excellence. (2007). Urinary tract infection in under 16s: diagnosis and management. Clinical guideline.. nice. org. uk/guidance/cg54.
Altuntas N, Tayfur AC, Kocak M, Razi HC, Akkurt S. Midstream clean-catch urine collection in newborns: a randomized controlled study. Eur J Pediatr. 2015 May;174(5):577-82. doi: 10.1007/s00431-014-2434-z. Epub 2014 Oct 17.
PubMed 25319844Herreros ML, Tagarro A, Garcia-Pose A, Sanchez A, Canete A, Gili P. Accuracy of a new clean-catch technique for diagnosis of urinary tract infection in infants younger than 90 days of age. Paediatr Child Health. 2015 Aug-Sep;20(6):e30-2.
PubMed 26435675
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06265142
- Acronym / sponsor ID
- MoH/CSR/23/26368
- Conditions
- Urinary Tract Infections
- Keywords
- clean catch urine, bladder massage, bladder catheterization, contamination rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.
Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.
Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.
Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.
Patient Population: young infants from 0 to 6 months of age
Intervention: There will be two groups:
- Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
- Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.
Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.
Outcome: Contamination rate and feasibility of both urine sampling techniques
Detailed description
Urinary tract infection (UTI) is a common source of infection in children. It accounts for 5 to 14 percent of visits by children every year. The overall prevalence is around 7% among different age subgroups of children. Several factors affect the prevalence of UTI including age, gender, and circumcision status.
The diagnosis of UTI requires obtaining a urine specimen from the patient. Generally, there are four methods used in collecting urine samples which can be categorized as invasive (such as suprapubic aspiration and urethral bladder catheterization) and noninvasive (such as Sterile bag and clean catch).
The selection of the urine collection technique is mainly determined by whether the patient is toilet-trained or not. In non-toilet-trained patients, urethral bladder catheterization or suprapubic aspiration can be used. The latter is having the least contamination rate in urine culture. Clean-catch urine is commonly used for toilet-trained patients. If the clinical assessment of febrile infants necessitates immediate antimicrobial therapy, urine culture should be obtained either by urethral bladder catheterization or suprapubic aspiration.
Previous observational studies showed approximately a 1 percent contamination rate using the suprapubic aspiration technique. In a prospective study done on premature infants it was found that the suprapubic aspiration technique resulted in increased pain and a higher probability of procedural failure compared to urethral bladder catheterization. According to American academy of pediatrics (AAP), for non-toilet trained children, it's advisable to gather a urine sample through methods like ureteral catheterization or suprapubic bladder aspiration, especially when a sample obtained using a perineal bag shows positive results on a dipstick test. The latest guideline from AAP recommends urine culture to be obtained via either SPA or bladder catheterization in pediatric patients aged between 8 to 60 days old, due to false positive results that can occur in the other urine collection techniques.
Urethral bladder catheterization carries a 6 to 12 percent of contamination rate. In regard clean catch urine method 16 to 63 percent of the contamination rate.
As outlined in the guideline in National Institute for Health and Care Excellence (NICE) guideline, to use clean catch urine wherever possible in pediatric patients below 16 years old. And to reserve bladder catheterization and suprapubic aspiration when noninvasive methods are not possible or practical.
previous literature demonstrated a safe and noninvasive technique to collect midstream clean-catch urine in infants. It was based on bladder stimulation and paravertebral lumbar massage. This technique yielded accurate and low contamination rates for infants below 90 days old. Moreover, the success rate was 86.3 percent, while the contamination rate was 5 percent. The safety and efficacy of the same stimulation technique in a neonatal intensive care unit setting were described in the literature. The median time to collect urine was 64 seconds. The success rate is 90 percent. However, some literature showed a lower success rate reaching 61 percent, possibly due to patients with a low oral intake that were not excluded from the study.
In the effort to reduce bladder catheterization in children, different techniques were introduced in the previous literature to improve the clean catch urine success rate as well as the contamination rate. Bladder and lumbar paravertebral massage maneuvers are a safe, time-saving technique that needs to be studied further.
In our setting, the recommendations from international guidelines are being followed. For non-toilet trained children suspected to have UTI, initial urine specimen for urine dipstick is collected by sterile bag or bladder catheterization. If the result of the urine dipstick came positive, then urine culture is obtained via bladder catheterization, if the initial specimen collected by the sterile bag. In addition, we lack the statistics of urine culture contamination in our laboratories.
The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patient will be assessed in triage and cases to be included in the study as per the inclusion criteria, after that patients will be randomized using computerized block randomization technique into two groups. Then, patients will be assigned to a bed, pulse oximetry to be applied, data collection sheet to be filled, confirm that infant had good feeding/ didn't pass urine over last 20 minutes and proper cleaning to be done. The next step will be, collecting urine sample according to randomization group. Group A patients (control group), urine to be collected by standardized catheterization technique while group B by standard CCU technique. Meanwhile, time of each procedure to be documented. Regarding group B , after collecting urine by CCU , we recommend to collect another sample by catheterization to guide the management and antibiotic choice.
| Arm | Type | Receives |
|---|---|---|
| Catheterization | Other | Procedure: Bladder catheterizationGroup A: is the control group, participant will undergo bladder catheterization. (The standard practice) |
| Clean Catch | Experimental | Procedure: clean catch urine via bladder massage techniqueGroup B: is the experimental group, participant will undergo clean catch urine via bladder massage technique. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Hemodynamically stable infants.
- Require urine collection as part of their work-up in the emergency department.
- Age 0 to 6 months.
Key exclusion criteria (2 listed)
- Parental refusal.
- Unstable hemodynamically young infants.
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 |
|---|---|---|
| Bladder catheterizationParticipant will undergo the standard bladder catheterization for urine collection | Procedure or surgery | Catheterization |
| clean catch urine via bladder massage techniqueParticipant will undergo clean catch urine via bladder massage technique | Procedure or surgery | Clean Catch |
Primary outcome
Urine culture contamination rate
Time frame: After urine culture report (usually 2-3 days after urine collection)
Urine culture contamination rate will be evaluated in both techniques used in the study which includes dividing the total number of contaminated urine culture sets by the total number of urine culture.
Parental satisfaction questionnaire
Time frame: After the procedure immediately
Parental satisfaction with the procedure techniques (in both arms) will be evaluated by a questionnaire.
2 secondary outcomes
duration of the procedure
Time frame: during each procedure
Pain score
Time frame: after the procedure immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 18316994Shaikh N, Morone NE, Bost JE, Farrell MH. Prevalence of urinary tract infection in childhood: a meta-analysis. Pediatr Infect Dis J. 2008 Apr;27(4):302-8. doi: 10.1097/INF.0b013e31815e4122.
- BackgroundNader, S. and Alejandro, H., 2021. Urinary tract infections in children: Epidemiology and risk factors. UpToDate, Waltham, MA, pp.1-19. (Accessed on January 01, 2023).
- Background: PubMed 21873693Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management; Roberts KB. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011 Sep;128(3):595-610. doi: 10.1542/peds.2011-1330. Epub 2011 Aug 28.
- Background: PubMed 16203935Schroeder AR, Newman TB, Wasserman RC, Finch SA, Pantell RH. Choice of urine collection methods for the diagnosis of urinary tract infection in young, febrile infants. Arch Pediatr Adolesc Med. 2005 Oct;159(10):915-22. doi: 10.1001/archpedi.159.10.915.
- Background: PubMed 22537082Tosif S, Baker A, Oakley E, Donath S, Babl FE. Contamination rates of different urine collection methods for the diagnosis of urinary tract infections in young children: an observational cohort study. J Paediatr Child Health. 2012 Aug;48(8):659-64. doi: 10.1111/j.1440-1754.2012.02449.x. Epub 2012 Apr 27.
- Background: PubMed 27542848Labrosse M, Levy A, Autmizguine J, Gravel J. Evaluation of a New Strategy for Clean-Catch Urine in Infants. Pediatrics. 2016 Sep;138(3):e20160573. doi: 10.1542/peds.2016-0573. Epub 2016 Aug 19.
- Background: PubMed 10931415Al-Orifi F, McGillivray D, Tange S, Kramer MS. Urine culture from bag specimens in young children: are the risks too high? J Pediatr. 2000 Aug;137(2):221-6. doi: 10.1067/mpd.2000.107466.
- Background: PubMed 34772880Bogie AL, Sparkman A, Anderson M, Crittenden-Byers C, Barron M. Is There a Difference in the Contamination Rates of Urine Samples Obtained by Bladder Catheterization and Clean-Catch Collection in Preschool Children? Pediatr Emerg Care. 2021 Dec 1;37(12):e788-e790. doi: 10.1097/PEC.0000000000002578.
- Background: PubMed 27289027Ballouhey Q, Fourcade L, Couve-Deacon E, Cros J, Lescure V, Bahans C, Chainier D, Garnier F, Guigonis V. Urine Contamination in Nontoilet-trained and Uncircumcised Boys. Urology. 2016 Sep;95:171-4. doi: 10.1016/j.urology.2016.05.056. Epub 2016 Jun 8.
- Background: PubMed 25317295Badiee Z, Sadeghnia A, Zarean N. Suprapubic Bladder Aspiration or Urethral Catheterization: Which is More Painful in Uncircumcised Male Newborns? Int J Prev Med. 2014 Sep;5(9):1125-30.
- Background: PubMed 33479164Mattoo TK, Shaikh N, Nelson CP. Contemporary Management of Urinary Tract Infection in Children. Pediatrics. 2021 Feb;147(2):e2020012138. doi: 10.1542/peds.2020-012138.
- Background: PubMed 34281996Pantell RH, Roberts KB, Adams WG, Dreyer BP, Kuppermann N, O'Leary ST, Okechukwu K, Woods CR Jr; SUBCOMMITTEE ON FEBRILE INFANTS. Evaluation and Management of Well-Appearing Febrile Infants 8 to 60 Days Old. Pediatrics. 2021 Aug;148(2):e2021052228. doi: 10.1542/peds.2021-052228. Epub 2021 Jul 19.
- Individual participant dataSharing planned: Undecided. Still undecided, as it is a pilot study. in the next main study, the IPD will be available.
Related trials for Urinary Tract Infections
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
RecruitingPhase 2
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
Chronic Urinary Tract Infection
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
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.
Lubna M Al Lawati, MD study director
Oman Medical Speciality Board
Questions about this trial
What is this clinical trial studying?
A study testing Bladder catheterization and clean catch urine via bladder massage technique in people with Urinary Tract Infections, run by Oman Medical Speciality Board.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sulayyem S Al Harsousi, MD (97383155 ext. +968, r2123@resident.omsb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine culture contamination rate (time frame: After urine culture report (usually 2-3 days after urine collection)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265142, which also lists 16 linked publications.
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 20 Feb 2024.