Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants

NCT04587999 | Completed

• 1 other identifier: 20-HPNCL-04
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 3

Brief Summary

Urinary tract infections are common in infants. Obtaining urine from pre-continent children can be difficult and time consuming. The method of collection must balance reliability, speed, low rate of contamination, and invasiveness. According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infections. However, it is impractical in pre-continent children. Recently, two quick, safe and effective methods have been reported in the literature:

• The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines.
• The bladder stimulation method : the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively. However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• volume of urine collection to measure the effectiveness of two techniques

  measure of success of the urine collection technique is determined by collecting at least 2 millimeters of urine in less than 5 minutes

  at the end of intervention completion, an average 30 minutes

Secondary Outcomes (4)

• time needed to obtain urines

  at the end of intervention completion, an average 30 minutes

• patient comfort

  through intervention completion, an average 30 minutes

• Bacterial contamination rates of urine samples

  at 48 hours after inclusion

• collection of patient data to define risk factors associated with the failure of the bladder stimulation techniques

  through intervention completion, an average 30 minutes

Study Arms (2)

bladder stimulation

EXPERIMENTAL

Other: bladder stimulation

Quick wee

ACTIVE COMPARATOR

Other: Quick wee

Interventions

bladder stimulation OTHER

The bladder stimulation technique requires the presence of 2 people: * The child must be held by an adult (caregiver or parent) under the armpits, legs dangling. * the first person (the investigator), performs the stimulation technique consisting of: rapid tapping (frequency of about 100 / min), over the pubic area, at the level of the bladder, alternated with external rotational movements of the pits lumbar, in the kidneys. Alternate these 2 maneuvers every 30 seconds. * The second person starts the stopwatch at the start of the stimulation, and is about to collect the urine, 2nd jet in a sterile pot * The maneuver ends as soon as urine is obtained, and will be stopped after 5 minutes in case of failure.

bladder stimulation

Quick wee OTHER

The Quick wee technique requires the presence of only one person: Stimulation of the suprapubic area by circular movements, with a cold and wet compress held by sterile forceps. Collection of urine in a sterile container.

Quick wee

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants under the age of 1 year, pre-continent, before walking
• For whom an urine sample is required for the diagnosis of a urinary tract infection, uropathy, nephropathy, metabolic disease
• Obtaining the authorization by one of the two parents or the holder of parental authority
• Affiliation to a national social security scheme

You may not qualify if:

• Do exhibiting signs of vital distress
• Withdrawal of informed consent by parents or holders of parental authority
• External genitalia or urinary tract malformation
• Bladder dysfunction

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (3)

Centre Hospitalier Universitaire de Sainte-Justine

Montreal, Canada

Location

Centre Hospitalier Antibes Juan les Pins

Antibes, France

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

Related Publications (1)

• 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.

  PMID: 34531206 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 14, 2020
• Study Start: January 29, 2021
• Primary Completion: June 6, 2022
• Study Completion: November 17, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

FR (2); CA (1)