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Completed

NCT Number: NCT02749188

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

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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Lenval

Nice, 06200, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bladder stimulation

Other

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

Primary outcomes

  1. Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking

    Time frame: During 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 outcomes

  1. evaluation period of urine collection

    Time frame: During baseline at time 0

    If successful, the evaluation period, in seconds, of urine collection using a chronometer (between the start of bladder stimulation and obtaining the urine)

  2. Evaluation of the tolerance of the infant

    Time frame: During baseline at time 0

    Evaluation of the tolerance of the infant undergoing stimulation technique using wide EVENDOL scale pain, noted on 15

  3. alternative of the urine sample

    Time frame: During baseline after 2 attemps of bladder stimulation

    In 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

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

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

Acronym: StiVeN

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2016
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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