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

Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants 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.

Study Overview

• Status: Completed
• Conditions: Urinary Retention
• Intervention / Treatment: Other: Bladder stimulation

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

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • Fondation Lenval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: bladder stimulation; 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.	Other: Bladder stimulation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking	• 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.	During baseline at time 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation period of urine collection	If successful, the evaluation period, in seconds, of urine collection using a chronometer (between the start of bladder stimulation and obtaining the urine)	During baseline at time 0
Evaluation of the tolerance of the infant	Evaluation of the tolerance of the infant undergoing stimulation technique using wide EVENDOL scale pain, noted on 15	During baseline at time 0
alternative of the urine sample	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	During baseline after 2 attemps of bladder stimulation

Collaborators and Investigators

• Sponsor: Fondation Lenval
• Investigators: Principal Investigator: Antoine TRAN, MD, Fondation Lenval

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Infant; Newborn; Feasibility Studies; Urine Specimen Collection/methods; Bladder stimulation
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 14-HPNCL-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No