Urine Specimen CollectionNCT05416736
The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns
A study testing The bladder stimulation technique and Steril urine bag in people with Urine Specimen Collection, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Urine specimen are necessary to diagnose various diseases in infants, especially urinary tract infections (UTI). Various non-invasive and invasive clinical interventions have been described for urine specimen collection. Read more about this study
- Who is it for?
- Ages 3 to 28 days
- Conditions the study is for
- Urine Specimen Collection
- What is being tested?
- The bladder stimulation technique and Steril urine bag
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 1 Nov 2022
- 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 3 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full-term newborns aged 3-28 days
- Collecting urine specimen
- Being fed orally
- Having written consent from parents
Who cannot join
- Poor general clinical condition (respiratory distress, etc.)
- Poor feding
- Dehydration
- Oliguria/anuria
- Treatment with nephrotoxic drugs
- Serious illnesses affecting the mobility of the baby
- Having neurological and anatomical anomalies that may affect bladder function Any condition (meningocele, meningomyelocele etc.) that will prevent the implementation of the stimulation maneuver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns: A Randomized Controlled Study
Urine specimen are necessary to diagnose various diseases in infants, especially urinary tract infections (UTI). Various non-invasive and invasive clinical interventions have been described for urine specimen collection. These; suprapubic aspiration, urinary catheterization, sterile urine collection bag and clean-caught urine (Herreros Fernández et al., 2013). For the diagnosis of UTI, it is recommended to collect urine samples by suprapubic aspiration (SPA) and urinary catheterization methods. However, these techniques are invasive and painful (Roberts et al. 2016). Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI. But this method is possible for children with sphincter control. A technique was recently described that allows midstream urine specimen collection in children without sphincter control. This technique consists of bladder stimulation and lumbar paravertebral massage. The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success, procedure time, physiological parameters and comfort in urine specimen collection in newborns.
Read the detailed description
Urinary Tract Infection (UTI) is common in early childhood. Urinary Tract Infection (UTI) is the most common bacterial infection in febrile children younger than 3 months of age (Korbel et al., 2017; Velasco et al., 2015). A clean urine sample is required to diagnose various diseases, especially urinary tract infections (UTI) in infants. Various non-invasive and invasive clinical interventions have been described for urine specimen collection. These; suprapubic aspiration, urinary catheterization, sterile urine collection bag, and clean-caught urine (Herreros Fernández et al., 2013).
One of the non-invasive methods used to collect urine samples is the use of sterile urine collection bags (Herreros Fernández et al., 2013). This method is not an effective method due to its high false positive rate, time consuming, delayed treatment, skin irritation and high risk of contamination (Finnell et al., 2011; Kaufman et al., 2020). Therefore, sterile urine bags should be used in urinalysis instead of urine culture (Balighian \& Review, 2018). Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI. However, this method is possible for children with sphincter control (Altuntas et al., 2015; Kaufman et al., 2019).
A technique was recently described that allows midstream urine specimen collection in children without sphincter control. The technique, consisting of bladder stimulation and lumbar paravertebral massage, was successful in 86% of newborns, with an average duration of 57 seconds (Herreros Fernández et al., 2013). Previous studies have evaluated the technique's success rate and processing time (Altuntas et al., 2015, Labrosse et al., 2016, Crombie et al., 2020), contamination rate (Herreros et al., 2021), and cost (Kaufman et al., 2020) examined. Examination of the effect of the technique on the comfort and physiological parameters of the newborn will contribute to more information about the technique.
The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success, procedure time, physiological parameters and comfort in urine specimen collection in newborns.
Study Population and Sampling The population of the research will be the newborns followed in the neonatal intensive care unit. The sample will consist of 64 (Experimental group = 32, Control group = 32) newborns who meet the inclusion criteria of the study. In calculating the sample size, Altuntaş et al. (2015) benefited from the study. Considering the success rates; The minimum number of samples to be taken was determined as 64 (Experimental group=32, Control group=32) with 95% confidence (1-α), 95% test power (1-β), w=0.453 effect size.
Randomization Infants meeting the research inclusion criteria will be divided into experimental and control groups using a computer-based program (https://www.randomizer.org).
Data Collection Method: The data will be collected by the a researcher in the unit where the study is planned to be carried out.
- Data Collection Form: Prepared by the researcher. The form includes questions about the infant's age, weight, gender, fever, heartbeat, saturation level, Comfortneo scale score, and procedure success and duration of the procedure.
- Comfortneo scale: Developed by Ambuel et al. (Ambuel et.al. 1992). Van Dijk et al. revised the COMFORTneo scale to measure behavior in newborns without physiological parameters (Van Dijk et. al. 2009). Turkish validity and reliability of the scale Kahraman et al. (Kahraman et. al 2014). The scale consists of 7 items: muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying. "Respiratory response" is scored in infants on mechanical ventilator, and "crying" is scored in spontaneously breathing infants. A total score is calculated over 6 items. The lowest score that can be obtained from this scale is 6, and the highest score is 30. A high score indicates that the baby is not comfortable and needs interventions to provide comfort (Kahraman et. al 2014).
- Pulse Oximeter Device to detect infants' oxygen saturation (SPO2) and heart rate (HR)
- Weighing Tool to determine the current weight of babies.
- Thermometer to determine babies' body temperature
- Conditions
- Urine Specimen Collection
- Being tested
- The bladder stimulation technique, Steril urine bag
- Keywords
- urine specimen, bladder stimulation technique, newborn, comfort, physiological parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The bladder stimulation techniqueProcedure or surgery
The bladder stimulation technique consists of two consecutive maneuvers. In the first maneuver, the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, circular massage is applied to the paravertebral region for 30 seconds. The two stimulation maneuvers will be repeated alternately for 3 minutes (180 seconds) until micturition begins. Maneuvers will be performed by the researcher. Infants in both groups will be held under the armpit by a parent, male infants will be held in the drooping legs, and female infants will be held in the hip flexion position.
Steril urine bagProcedure or surgery
Also called Sterile urine bag
Steril urine bag are attached to the genital area to collect urine samples
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | * Newborns will be fed with formula or breast milk pumped, according to the age and weight of the baby.
* Before the procedure, the newborn's heart rate, saturation and comfort scale score will be recorded.
* Genital area will be cleaned.
* Newborn will be held under the armpit by a nurse, baby boys will be held with their legs hanging down, and baby girls will be held in hip flexion position.
* Newborn with spontaneous voiding during the period from the beginning of the research procedure until the newborn is positioned will be excluded from the study.
* The bladder stimulation technique will be repeated sequentially for 3 minutes until micturition begins.
* After the maneuvers are started, the newborn's heart rate and saturation comfort scale score will be recorded at the 1st and 3rd minutes.
* The success of the procedure and the duration of the procedure will be recorded Receives: Procedure: The bladder stimulation technique |
| Control Group | Active comparator | * Newborns will be fed with formula or breast milk pumped, according to the age and weight of the baby.
* Before the procedure, the newborn's heart rate, saturation and comfort scale score will be recorded.
* Genital area will be cleaned.
* Newborns will be fitted with a sterile urine bag suitable for their gender.
* Babies who urinate spontaneously during the period until the sterile urine bag is fitted, the next feeding hour will be waited.
* Newborn will be observed for 3 minutes. Newborn's heart rate and saturation comfort pain scale score will be recorded at the 1st and 3rd minutes.
* The success of the procedure and the duration of the procedure will be recorded Receives: Procedure: Steril urine bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Procedural success is defined as urine sample collection within 3 minutes (180 seconds) of starting the stimulation maneuvers.
Measured: During the procedure (3 minutes)
Duration of the procedure
Duration of the procedure is defined as the time from the beginning of bladder stimulation to the beginning of micturition
Measured: During the procedure (3 minutes)
Secondary outcomes (3)
Comfort
The comfort levels of the newborns during the procedure will determined by the researcher.
Measured: Before the procedure, at the 1st and 3rd minutes]
Heart rate
The heart rate of the infants will measured with hand portable pulse oximeter
Measured: Before the procedure, at the 1st and 3rd minutes]
Peripheral oxygen saturation level
The peripheral oxygen saturation levels of the infants will measured with hand portable pulse oximeter
Measured: Before the procedure, at the 1st and 3rd minutes]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start15 Oct 2021
- Primary completion1 Sep 2022
- Study completion1 Nov 2022
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 Urine Specimen CollectionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental design
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Korkmaz, Istanbul University - Cerrahpasa
- Investigators
- Fatma Narter Kaya, Principal investigator, Dr. Lutfi Kirdar Kartal Training and Research HospitalBirsen Mutlu, Principal investigator, Istanbul University - CerrahpasaNihan Korkmaz, Principal investigator, Istanbul University - CerrahpasaKadriye Şahin, Principal investigator, Istanbul University - CerrahpasaHande Özgürü, Principal investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416736
- Sponsor's protocol ID
- Nihan
- Status last verified
- Nov 2022
- First submitted
- 9 Jun 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.
PubMed 23172785Korbel L, Howell M, Spencer JD. The clinical diagnosis and management of urinary tract infections in children and adolescents. Paediatr Int Child Health. 2017 Nov;37(4):273-279. doi: 10.1080/20469047.2017.1382046. Epub 2017 Oct 5.
PubMed 28978286Velasco R, Benito H, Mozun R, Trujillo JE, Merino PA, Mintegi S; Group for the Study of Febrile Infant of the RISeuP-SPERG Network. Febrile young infants with altered urinalysis at low risk for invasive bacterial infection. a Spanish Pediatric Emergency Research Network's Study. Pediatr Infect Dis J. 2015 Jan;34(1):17-21. doi: 10.1097/INF.0000000000000482.
PubMed 25036049SUBCOMMITTEE ON URINARY TRACT INFECTION. Reaffirmation of AAP Clinical Practice Guideline: The Diagnosis and Management of the Initial Urinary Tract Infection in Febrile Infants and Young Children 2-24 Months of Age. Pediatrics. 2016 Dec;138(6):e20163026. doi: 10.1542/peds.2016-3026. No abstract available.
PubMed 27940735Finnell SM, Carroll AE, Downs SM; Subcommittee on Urinary Tract Infection. Technical report-Diagnosis and management of an initial UTI in febrile infants and young children. Pediatrics. 2011 Sep;128(3):e749-70. doi: 10.1542/peds.2011-1332. Epub 2011 Aug 28.
PubMed 21873694Kaufman J. How to... collect urine samples from young children. Arch Dis Child Educ Pract Ed. 2020 Jun;105(3):164-171. doi: 10.1136/archdischild-2019-317237. Epub 2019 Aug 23.
PubMed 31444213Balighian E, Burke M. Urinary Tract Infections in Children. Pediatr Rev. 2018 Jan;39(1):3-12. doi: 10.1542/pir.2017-0007. No abstract available.
PubMed 29292282Altuntas 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 25319844Labrosse 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 27542848Crombie T, Slinger R, Barrowman NJ, McGahern C, Smith L, Chu J, McCoy K, Akiki S, Agarwal A, Plint AC. Pragmatic evaluation of a midstream urine collection technique for infants in the emergency department. CJEM. 2020 Sep;22(5):665-672. doi: 10.1017/cem.2020.31.
PubMed 32383423Herreros ML, Gili P, Del Valle R, Barrios A, Pacheco M, Sanchez A. Urine collection methods for infants under 3 months of age in clinical practice. Pediatr Nephrol. 2021 Dec;36(12):3899-3904. doi: 10.1007/s00467-021-05142-4. Epub 2021 Jun 7.
PubMed 34100109Kaufman J, Knight AJ, Bryant PA, Babl FE, Dalziel K. Liquid gold: the cost-effectiveness of urine sample collection methods for young precontinent children. Arch Dis Child. 2020 Mar;105(3):253-259. doi: 10.1136/archdischild-2019-317561. Epub 2019 Aug 23.
PubMed 31444211Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95.
PubMed 1545324van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
PubMed 19692803Kahraman A, Başbakkal Z, Yalaz M. Turkish Validity And Reliability Of Comfortneo Scale. International Refereed Journal of Nursing Research. 2014; 1: 1-11
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05416736
- Acronym / sponsor ID
- Nihan
- Conditions
- Urine Specimen Collection
- Keywords
- urine specimen, bladder stimulation technique, newborn, comfort, physiological parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 13 Jun 2022 (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.
Urine specimen are necessary to diagnose various diseases in infants, especially urinary tract infections (UTI). Various non-invasive and invasive clinical interventions have been described for urine specimen collection. These; suprapubic aspiration, urinary catheterization, sterile urine collection bag and clean-caught urine (Herreros Fernández et al., 2013). For the diagnosis of UTI, it is recommended to collect urine samples by suprapubic aspiration (SPA) and urinary catheterization methods. However, these techniques are invasive and painful (Roberts et al. 2016). Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI. But this method is possible for children with sphincter control. A technique was recently described that allows midstream urine specimen collection in children without sphincter control. This technique consists of bladder stimulation and lumbar paravertebral massage. The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success, procedure time, physiological parameters and comfort in urine specimen collection in newborns.
Detailed description
Urinary Tract Infection (UTI) is common in early childhood. Urinary Tract Infection (UTI) is the most common bacterial infection in febrile children younger than 3 months of age (Korbel et al., 2017; Velasco et al., 2015). A clean urine sample is required to diagnose various diseases, especially urinary tract infections (UTI) in infants. Various non-invasive and invasive clinical interventions have been described for urine specimen collection. These; suprapubic aspiration, urinary catheterization, sterile urine collection bag, and clean-caught urine (Herreros Fernández et al., 2013).
One of the non-invasive methods used to collect urine samples is the use of sterile urine collection bags (Herreros Fernández et al., 2013). This method is not an effective method due to its high false positive rate, time consuming, delayed treatment, skin irritation and high risk of contamination (Finnell et al., 2011; Kaufman et al., 2020). Therefore, sterile urine bags should be used in urinalysis instead of urine culture (Balighian \& Review, 2018). Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI. However, this method is possible for children with sphincter control (Altuntas et al., 2015; Kaufman et al., 2019).
A technique was recently described that allows midstream urine specimen collection in children without sphincter control. The technique, consisting of bladder stimulation and lumbar paravertebral massage, was successful in 86% of newborns, with an average duration of 57 seconds (Herreros Fernández et al., 2013). Previous studies have evaluated the technique's success rate and processing time (Altuntas et al., 2015, Labrosse et al., 2016, Crombie et al., 2020), contamination rate (Herreros et al., 2021), and cost (Kaufman et al., 2020) examined. Examination of the effect of the technique on the comfort and physiological parameters of the newborn will contribute to more information about the technique.
The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success, procedure time, physiological parameters and comfort in urine specimen collection in newborns.
Study Population and Sampling The population of the research will be the newborns followed in the neonatal intensive care unit. The sample will consist of 64 (Experimental group = 32, Control group = 32) newborns who meet the inclusion criteria of the study. In calculating the sample size, Altuntaş et al. (2015) benefited from the study. Considering the success rates; The minimum number of samples to be taken was determined as 64 (Experimental group=32, Control group=32) with 95% confidence (1-α), 95% test power (1-β), w=0.453 effect size.
Randomization Infants meeting the research inclusion criteria will be divided into experimental and control groups using a computer-based program (https://www.randomizer.org).
Data Collection Method: The data will be collected by the a researcher in the unit where the study is planned to be carried out.
- Data Collection Form: Prepared by the researcher. The form includes questions about the infant's age, weight, gender, fever, heartbeat, saturation level, Comfortneo scale score, and procedure success and duration of the procedure.
- Comfortneo scale: Developed by Ambuel et al. (Ambuel et.al. 1992). Van Dijk et al. revised the COMFORTneo scale to measure behavior in newborns without physiological parameters (Van Dijk et. al. 2009). Turkish validity and reliability of the scale Kahraman et al. (Kahraman et. al 2014). The scale consists of 7 items: muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying. "Respiratory response" is scored in infants on mechanical ventilator, and "crying" is scored in spontaneously breathing infants. A total score is calculated over 6 items. The lowest score that can be obtained from this scale is 6, and the highest score is 30. A high score indicates that the baby is not comfortable and needs interventions to provide comfort (Kahraman et. al 2014).
- Pulse Oximeter Device to detect infants' oxygen saturation (SPO2) and heart rate (HR)
- Weighing Tool to determine the current weight of babies.
- Thermometer to determine babies' body temperature
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: The bladder stimulation technique* Newborns will be fed with formula or breast milk pumped, according to the age and weight of the baby. * Before the procedure, the newborn's heart rate, saturation and comfort scale score will be recorded. * Genital area will be cleaned. * Newborn will be held under the armpit by a nurse, baby boys will be held with their legs hanging down, and baby girls will be held in hip flexion position. * Newborn with spontaneous voiding during the period from the beginning of the research procedure until the newborn is positioned will be excluded from the study. * The bladder stimulation technique will be repeated sequentially for 3 minutes until micturition begins. * After the maneuvers are started, the newborn's heart rate and saturation comfort scale score will be recorded at the 1st and 3rd minutes. * The success of the procedure and the duration of the procedure will be recorded |
| Control Group | Active comparator | Procedure: Steril urine bag* Newborns will be fed with formula or breast milk pumped, according to the age and weight of the baby. * Before the procedure, the newborn's heart rate, saturation and comfort scale score will be recorded. * Genital area will be cleaned. * Newborns will be fitted with a sterile urine bag suitable for their gender. * Babies who urinate spontaneously during the period until the sterile urine bag is fitted, the next feeding hour will be waited. * Newborn will be observed for 3 minutes. Newborn's heart rate and saturation comfort pain scale score will be recorded at the 1st and 3rd minutes. * The success of the procedure and the duration of the procedure will be recorded |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Full-term newborns aged 3-28 days
- Collecting urine specimen
- Being fed orally
- Having written consent from parents
Key exclusion criteria (7 listed)
- Poor general clinical condition (respiratory distress, etc.)
- Poor feding
- Dehydration
- Oliguria/anuria
- Treatment with nephrotoxic drugs
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 bladder stimulation techniqueThe bladder stimulation technique consists of two consecutive maneuvers. In the first maneuver, the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, circular massage is applied to the paravertebral region for 30 seconds. The two stimulation maneuvers will be repeated alternately for 3 minutes (180 seconds) until micturition begins. Maneuvers will be performed by the researcher. Infants in both groups will be held under the armpit by a parent, male infants will be held in the drooping legs, and female infants will be held in the hip flexion position. | Procedure or surgery | Experimental Group |
| Steril urine bagAlso: Sterile urine bagSteril urine bag are attached to the genital area to collect urine samples | Procedure or surgery | Control Group |
Primary outcome
Procedural success
Time frame: During the procedure (3 minutes)
Procedural success is defined as urine sample collection within 3 minutes (180 seconds) of starting the stimulation maneuvers.
Duration of the procedure
Time frame: During the procedure (3 minutes)
Duration of the procedure is defined as the time from the beginning of bladder stimulation to the beginning of micturition
3 secondary outcomes
Comfort
Time frame: Before the procedure, at the 1st and 3rd minutes]
Heart rate
Time frame: Before the procedure, at the 1st and 3rd minutes]
Peripheral oxygen saturation level
Time frame: Before the procedure, at the 1st and 3rd minutes]
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 14 Nov 2022.
- Background: PubMed 23172785Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.
- Background: PubMed 28978286Korbel L, Howell M, Spencer JD. The clinical diagnosis and management of urinary tract infections in children and adolescents. Paediatr Int Child Health. 2017 Nov;37(4):273-279. doi: 10.1080/20469047.2017.1382046. Epub 2017 Oct 5.
- Background: PubMed 25036049Velasco R, Benito H, Mozun R, Trujillo JE, Merino PA, Mintegi S; Group for the Study of Febrile Infant of the RISeuP-SPERG Network. Febrile young infants with altered urinalysis at low risk for invasive bacterial infection. a Spanish Pediatric Emergency Research Network's Study. Pediatr Infect Dis J. 2015 Jan;34(1):17-21. doi: 10.1097/INF.0000000000000482.
- Background: PubMed 27940735SUBCOMMITTEE ON URINARY TRACT INFECTION. Reaffirmation of AAP Clinical Practice Guideline: The Diagnosis and Management of the Initial Urinary Tract Infection in Febrile Infants and Young Children 2-24 Months of Age. Pediatrics. 2016 Dec;138(6):e20163026. doi: 10.1542/peds.2016-3026. No abstract available.
- Background: PubMed 21873694Finnell SM, Carroll AE, Downs SM; Subcommittee on Urinary Tract Infection. Technical report-Diagnosis and management of an initial UTI in febrile infants and young children. Pediatrics. 2011 Sep;128(3):e749-70. doi: 10.1542/peds.2011-1332. Epub 2011 Aug 28.
- Background: PubMed 31444213Kaufman J. How to... collect urine samples from young children. Arch Dis Child Educ Pract Ed. 2020 Jun;105(3):164-171. doi: 10.1136/archdischild-2019-317237. Epub 2019 Aug 23.
- Background: PubMed 29292282Balighian E, Burke M. Urinary Tract Infections in Children. Pediatr Rev. 2018 Jan;39(1):3-12. doi: 10.1542/pir.2017-0007. No abstract available.
- Background: PubMed 25319844Altuntas 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.
- 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 32383423Crombie T, Slinger R, Barrowman NJ, McGahern C, Smith L, Chu J, McCoy K, Akiki S, Agarwal A, Plint AC. Pragmatic evaluation of a midstream urine collection technique for infants in the emergency department. CJEM. 2020 Sep;22(5):665-672. doi: 10.1017/cem.2020.31.
- Background: PubMed 34100109Herreros ML, Gili P, Del Valle R, Barrios A, Pacheco M, Sanchez A. Urine collection methods for infants under 3 months of age in clinical practice. Pediatr Nephrol. 2021 Dec;36(12):3899-3904. doi: 10.1007/s00467-021-05142-4. Epub 2021 Jun 7.
- Background: PubMed 31444211Kaufman J, Knight AJ, Bryant PA, Babl FE, Dalziel K. Liquid gold: the cost-effectiveness of urine sample collection methods for young precontinent children. Arch Dis Child. 2020 Mar;105(3):253-259. doi: 10.1136/archdischild-2019-317561. Epub 2019 Aug 23.
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Carcinoma, Cancer
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
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.
Fatma Narter Kaya principal investigator
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Birsen Mutlu principal investigator
Istanbul University - Cerrahpasa
Nihan Korkmaz principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The bladder stimulation technique and Steril urine bag in people with Urine Specimen Collection, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 7 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Procedural success (time frame: During the procedure (3 minutes)). 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 NCT05416736, 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 14 Nov 2022.