InfantNCT07075094
Determination of the Effectiveness of Two Different Noninvasive Stimulation Methods in Urine Collection in Infants
A study testing Bladder stimulation and Subrapubic cutaneous stimulation in people with Infant and Urine, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effects of bladder stimulation and subrapubic cutaneous stimulation techniques applied during urine sampling in infants on the success of urine sampling, pain and procedure time. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Infant, Urine, Nursing Interventions
- What is being tested?
- Bladder stimulation and Subrapubic cutaneous stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Sep 2025
- 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 month to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A urine sample must be collected due to suspicion of a urinary tract infection,
- The infant must be being fed orally,
- The skin in the area where the maneuver will be performed must be intact,
- The infant must be conscious and have stable vital signs.
- The infant must be from families that can speak and understand Turkish and are willing to participate in the study
Who cannot join
- Presence of respiratory distress and signs of dehydration,
- Presence of a diagnosed chronic health problem,
- Presence of a neurological or anatomical abnormality that may affect bladder function,
- Presence of any diagnostic suspicion (distension, intussusception, appendicitis, etc.) that would preclude the application of the stimulation maneuver,
- Presence of cold stress.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effectiveness of Two Different Noninvasive Stimulation Methods in Urine Collection in Infants: A Randomized Controlled Trial
This study will be conducted to determine the effects of bladder stimulation and subrapubic cutaneous stimulation techniques applied during urine sampling in infants on the success of urine sampling, pain and procedure time.
Read the detailed description
Urinary tract infections are common in children. Urine samples and urinalysis are needed to confirm the diagnosis of urinary tract infection. Various invasive and noninvasive techniques are used for urine sample collection in children. These techniques include suprapubic aspiration, urinary catheterization, a sterile urine bag, and clean catch techniques. The clean catch technique is a commonly used noninvasive technique for urine sample collection in children. Parents have described clean catch urine collection in children who are not toilet-trained as time-consuming and complex. Alternative techniques that stimulate voiding in children who are not toilet-trained, allowing for quicker collection of urine samples using clean catch techniques, are beneficial. The noninvasive stimulation methods whose effectiveness in infant urine collection will be evaluated in this study are bladder stimulation and suprapubic cutaneous stimulation.
- Conditions
- Infant, Urine, Nursing Interventions
- Being tested
- Bladder stimulation, Subrapubic cutaneous stimulation
- Keywords
- Infant, Urine collection, Noninvasive stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder stimulationProcedure or surgery
This stimulation consists of two stages. In the first maneuver, the bladder is stimulated by gentle tapping of the suprapubic area for 30 seconds. In the second maneuver, the paravertebral area is massaged in a circular motion for 30 seconds. The two stimulation maneuvers are repeated sequentially for 5 minutes.
Subrapubic cutaneous stimulationProcedure or surgery
Circular rubbing movements will be made on the baby's suprapubic area with gauze soaked in cold salt water until micturition begins.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Urine samples from infants in the control group will be collected according to the clinic's routine practice. Unlike routine practice, these infants will be positioned to ensure similarity to the experimental groups. Urine samples will be collected in an upright position, held under the arms. No noninvasive stimulation will be used. |
| Bladder stimulation | Experimental | These babies will be held in an upright position by holding them under their arms during the urine sample collection process. A bladder stimulation technique will be used during the procedure. Receives: Procedure: Bladder stimulation |
| Subrapubic cutaneous stimulation | Experimental | These babies will be held in an upright position by holding them under their arms during the urine sample collection process. A subrapubic cutaneous stimulation technique will be used during the procedure. Receives: Procedure: Subrapubic cutaneous stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural pain score- FLACC Pain Scale
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale consists of five categories (face, legs, activity, crying, and consolability), and each category is scored between 0 and 2 depending on the pain or distress behaviors observed. The total score ranges from 0 to 10, with 0 indicating no pain or distress and 10 indicating extreme pain or distress. The FLACC scale was developed to assess pain in children aged 2 months to 7 years and is one of the widely recommended scales for assessing pain and distress among pediatric patients.
Measured: At the beginning of the procedure, at the end of the procedure
Urine sample collection success
Infants who can have a urine sample collected during the procedure will be recorded as having a successful procedure.
Measured: During the procedure (Average 5 minutes)
Secondary outcomes (1)
Procedure time
Procedure time is the time between the start of the stimulation method and the start of micturition.
Measured: Through the procedure completion, an average of 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Jul 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfantStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to experimental and control groups using block randomization method. Age and sex variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated two times (2X2X6) and 24 infant will be included in each group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Aytekin Ozdemir, Istanbul Medeniyet University
- Investigators
- Aynur Aytekin Ozdemir, Professor, Study director, İstanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075094
- Sponsor's protocol ID
- 2025-01/77
- Status last verified
- Nov 2025
- First submitted
- 11 Jul 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
Publications
Marchal S, Janicot J, Salicis J, Demonchy D, Herisse AL, Olla M, Rancurel A, Haas H, Berard E, Breaud J, Bernardor J, Ribet C, Freyssinet E, Donzeau D, Desmontils J, Schori-Fortier C, Fontas E, Tran A. Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U). BMJ Open. 2021 Sep 16;11(9):e046324. doi: 10.1136/bmjopen-2020-046324.
PubMed 34531206Korkmaz N, Narter FK, Mutlu B, Sahin K, Ozgoru H. Effects of the bladder stimulation technique on urine sample collection in newborns: A randomized controlled study. Int J Nurs Pract. 2024 Oct;30(5):e13255. doi: 10.1111/ijn.13255. Epub 2024 Apr 15.
PubMed 38622105
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effectiveness of Two Different Noninvasive Stimulation Methods in Urine Collection in Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07075094
- Acronym / sponsor ID
- 2025-01/77
- Conditions
- Infant, Urine, Nursing Interventions
- Keywords
- Infant, Urine collection, Noninvasive stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 20 Jul 2025 (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.
This study will be conducted to determine the effects of bladder stimulation and subrapubic cutaneous stimulation techniques applied during urine sampling in infants on the success of urine sampling, pain and procedure time.
Detailed description
Urinary tract infections are common in children. Urine samples and urinalysis are needed to confirm the diagnosis of urinary tract infection. Various invasive and noninvasive techniques are used for urine sample collection in children. These techniques include suprapubic aspiration, urinary catheterization, a sterile urine bag, and clean catch techniques. The clean catch technique is a commonly used noninvasive technique for urine sample collection in children. Parents have described clean catch urine collection in children who are not toilet-trained as time-consuming and complex. Alternative techniques that stimulate voiding in children who are not toilet-trained, allowing for quicker collection of urine samples using clean catch techniques, are beneficial. The noninvasive stimulation methods whose effectiveness in infant urine collection will be evaluated in this study are bladder stimulation and suprapubic cutaneous stimulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be assigned to experimental and control groups using block randomization method. Age and sex variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated two times (2X2X6) and 24 infant will be included in each group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Urine samples from infants in the control group will be collected according to the clinic's routine practice. Unlike routine practice, these infants will be positioned to ensure similarity to the experimental groups. Urine samples will be collected in an upright position, held under the arms. No noninvasive stimulation will be used. |
| Bladder stimulation | Experimental | Procedure: Bladder stimulationThese babies will be held in an upright position by holding them under their arms during the urine sample collection process. A bladder stimulation technique will be used during the procedure. |
| Subrapubic cutaneous stimulation | Experimental | Procedure: Subrapubic cutaneous stimulationThese babies will be held in an upright position by holding them under their arms during the urine sample collection process. A subrapubic cutaneous stimulation technique will be used during the procedure. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A urine sample must be collected due to suspicion of a urinary tract infection,
- The infant must be being fed orally,
- The skin in the area where the maneuver will be performed must be intact,
- The infant must be conscious and have stable vital signs.
- The infant must be from families that can speak and understand Turkish and are willing to participate in the study
Key exclusion criteria (5 listed)
- Presence of respiratory distress and signs of dehydration,
- Presence of a diagnosed chronic health problem,
- Presence of a neurological or anatomical abnormality that may affect bladder function,
- Presence of any diagnostic suspicion (distension, intussusception, appendicitis, etc.) that would preclude the application of the stimulation maneuver,
- Presence of cold stress.
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 stimulationThis stimulation consists of two stages. In the first maneuver, the bladder is stimulated by gentle tapping of the suprapubic area for 30 seconds. In the second maneuver, the paravertebral area is massaged in a circular motion for 30 seconds. The two stimulation maneuvers are repeated sequentially for 5 minutes. | Procedure or surgery | Bladder stimulation |
| Subrapubic cutaneous stimulationCircular rubbing movements will be made on the baby's suprapubic area with gauze soaked in cold salt water until micturition begins. | Procedure or surgery | Subrapubic cutaneous stimulation |
Primary outcome
Procedural pain score- FLACC Pain Scale
Time frame: At the beginning of the procedure, at the end of the procedure
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale consists of five categories (face, legs, activity, crying, and consolability), and each category is scored between 0 and 2 depending on the pain or distress behaviors observed. The total score ranges from 0 to 10, with 0 indicating no pain or distress and 10 indicating extreme pain or distress. The FLACC scale was developed to assess pain in children aged 2 months to 7 years and is one of the widely recommended scales for assessing pain and distress among pediatric patients.
Urine sample collection success
Time frame: During the procedure (Average 5 minutes)
Infants who can have a urine sample collected during the procedure will be recorded as having a successful procedure.
1 secondary outcome
Procedure time
Time frame: Through the procedure completion, an average of 5 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 20 Nov 2025.
- Background: PubMed 34531206Marchal S, Janicot J, Salicis J, Demonchy D, Herisse AL, Olla M, Rancurel A, Haas H, Berard E, Breaud J, Bernardor J, Ribet C, Freyssinet E, Donzeau D, Desmontils J, Schori-Fortier C, Fontas E, Tran A. Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U). BMJ Open. 2021 Sep 16;11(9):e046324. doi: 10.1136/bmjopen-2020-046324.
- Background: PubMed 38622105Korkmaz N, Narter FK, Mutlu B, Sahin K, Ozgoru H. Effects of the bladder stimulation technique on urine sample collection in newborns: A randomized controlled study. Int J Nurs Pract. 2024 Oct;30(5):e13255. doi: 10.1111/ijn.13255. Epub 2024 Apr 15.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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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.
Aynur Aytekin Ozdemir, Professor study director
İstanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder stimulation and Subrapubic cutaneous stimulation in people with Infant and Urine, run by Istanbul Medeniyet University 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 5 inclusion and 5 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 20 Nov 2025. 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 pain score- FLACC Pain Scale (time frame: At the beginning of the procedure, at the end of the procedure). 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 NCT07075094, which also lists 2 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 Nov 2025.