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Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infant Who Have Not Acquired Walking

Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02749188
Acronym
StiVeN
Enrollment
43
Registered
2016-04-22
Start date
2014-10-31
Completion date
2017-10-10
Last updated
2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

Keywords

Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation

Brief summary

The urinary tract infections are common in children. It is estimated that about 3% of girls and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae. Currently, there are different methods of urine collection, such as suprapubic aspiration, the survey, the collection bag and the jet medium collection. They have in common to be time-consuming, invasive in some cases, providers of contaminated levies for others and impossible in children incontinent for the last. A Spanish study developed a new collection technique, for kidney and bladder stimulation, noninvasive, in the new-born to 30-day months. The results are promising with a success rate of over 85% within a period of about 45s. No study has looked at a broader pediatric population, including children from birth to age of acquisition of walking. We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in infants who have not acquired the works for which a urine sample is required.

Detailed description

The urinary tract infections are common in children. It is estimated that about 3% of girls and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae. Currently, there are different methods of urine collection, such as suprapubic aspiration, the survey, the collection bag and the jet medium collection. They have in common to be time-consuming, invasive in some cases, providers of contaminated levies for others and impossible in children incontinent for the last. A Spanish study developed a new collection technique, for kidney and bladder stimulation, noninvasive, in the new-born to 30-day months. The results are promising with a success rate of over 85% within a period of about 45s. No study has looked at a broader pediatric population, including children from birth to age of acquisition of walking. We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in infants who have not acquired the works for which a urine sample is required. The main objective is the Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking

Interventions

Bladder stimulation as a noninvasive technique of urine collection. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes

Sponsors

Fondation Lenval
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
Yes

Inclusion criteria

* Infants under the age of 2 years and who have not acquired walking * To which the investigating doctor asked the indication of a urine sample in search of a urinary tract infection, ionic and metabolic disorder * Do not exhibiting signs of vital distress (respiratory or circulatory or neurological) * To which the bladder stimulation does not delay the treatment * Obtaining the authorization of the holders of parental authority * Affiliation to social security * Clinical examination

Exclusion criteria

* Parental Refusal * Infants\> 2 years or who has walking * Infant occurring outside the pediatric emergency timetables of care permanently * Infant having vital signs of distress (respiratory and / or circulatory and / or neurological) * Infant for which the bladder stimulation could delay the management

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walkingDuring baseline at time 0• Obtaining urine or not (YES / NO) by bladder stimulation in less than 3 minutes (max 2 attempts). This is evaluated by an investigator who directs the bladder stimulation technique.

Secondary

MeasureTime frameDescription
evaluation period of urine collectionDuring baseline at time 0If successful, the evaluation period, in seconds, of urine collection using a chronometer (between the start of bladder stimulation and obtaining the urine)
Evaluation of the tolerance of the infantDuring baseline at time 0Evaluation of the tolerance of the infant undergoing stimulation technique using wide EVENDOL scale pain, noted on 15
alternative of the urine sampleDuring baseline after 2 attemps of bladder stimulationIn case of failure, the investigator who included infants in the study will specify the alternative of the urine sample from: collection bag, survey, suprapubic aspiration, and the success or failure of this alternative

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026