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

Urinary Retention Clinical Trial

— StiVeN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749188
• Other study ID #: 14-HPNCL-07
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 10, 2017

Study information

• Verified date: April 2018
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

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

Locations

Country	Name	City	State
France	Fondation Lenval	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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