Feasibility of Bladder Stimulation in Infants

NCT02569944 | Completed

• 1 other identifier: PEDHURH-001
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomize trial by including patients up to 12 months old in whom a urine sample by a non-sterile method was requested under physician criteria. Intention-to-treat analysis was made. Urine dipstick was considered as altered if it was positive in leukoesterase test (≥2+) or nitrite test. In patients with an altered urine dipstick, a sterile sample was obtained for culture. If there was an initial altered urine dipstick with a subsequent negative urine culture it was considered as contaminated urine.

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Urine sample collection

  Primary outcome is the obtention of an urine sample within the time determinate for each technique. Bladder stimulation technique is a procedure that lasts 5 minutes (300 seconds). If urine sample was obtained of patients that underwent this technique, it was considered a success. if not, a failure. The same was determined for the perineal bag group. In this case, our hospital's protocol recommends to use a perineal bag no longer than 30 minutes, due to risk of contamination, and after three attempts, to consider other options, so in the patients that a perineal bag was placed, if obtaining a urine sample within 90 min (5400 seconds) was considered a success. Otherwise, it was considered as a failure. For the purpose of the primary objective of the study, rate of falilures of each technique was compared.

  5400 seconds

Study Arms (2)

perineal bag

ACTIVE COMPARATOR

Perineal bag was placed in infants to collect an urine sample.

Procedure: Perineal bag

Bladder stimulation

EXPERIMENTAL

Bladder stimulation technique was used in infants of this arm to obtain an urine sample

Procedure: Bladder stimulation

Interventions

Bladder stimulation PROCEDURE

Patients included in this arm were stimulated to collect urine with bladder stimulation technique. This technique consists in a tapping movement in the suprapubic area, followed by a circular massage in sacral zone. This sequence lasts one minute and it is repeated five times. No other procedure, drug or device was done/used in this patients.

Bladder stimulation

Perineal bag PROCEDURE

Patients included in this arm were placed a perineal bag to collect urine sample. No other procedure, drug or device was done/used in this patients.

perineal bag

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• infants up to one-year-old in whom a urine sample by a non-sterile method was requested under physician criteria and a written consent was signed by parents/caregivers.

You may not qualify if:

• patients in whom a urine sample obtained by sterile method was needed by protocol (i.e. febrile infants less than 3 months old)
• patients with underlying disease unable to oral intake of liquids
• patients whom parents/caregivers refused to sign the informed consent.

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

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: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 7, 2015
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 7, 2015

Record last verified: 2015-10