Feasibility of Bladder Stimulation in Infants

NCT ID: NCT02569944

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-12-31

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.

Detailed Description

Randomised not-blind trial developed between june 1st, 2013 and December 31st, 2014 at the Pediatric Emergency Department (PED) of Rio Hortega Universitary Hospital, a secondary hospital located in Valladolid (Spain).

Participants were 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.

The study obtained the approval of Western Valladolid Review Board.

Exclusion criteria:

Patients were excluded from the study if they met at least one of the following criteria: a) patients in whom a urine sample obtained by sterile method was needed by protocol (i.e. febrile infants less than 3 months old), b) patients with underlying disease unable to oral intake of liquids, c) patients whom parents/caregivers refused to sign the informed consent.

Randomization process:

Patients were assigned to one of the 2 groups of treatment (BS vs. PB) following a 1:1 ratio randomization sequence generated by one of the investigators (RV) using Stata® 12. (Stata Corp, College Station, Texas). After being generated, the sequence was introduced in opaque envelopes sequentially numbered.

Design of the study When, under physician criteria, it was decided to obtain a urine sample by a non-sterile method and the nurse staff that participates in the study were present at the shift, informed consent was asked to parents/caregivers. Once the consent was signed, the nurse opened the corresponding envelope, and the patient was assigned to one of the groups.

For each participant, the nurse that developed the technique filled a spreadsheet with data of the patient. Time was measured by using a stopwatch (the same one for all patients) that was not used for any purpose but the study. Urine sample was sent to the laboratory where one analyst performed the leukocyte-esterase and nitrite test. The analyst has no knowledge about the technique used on each patient and the result of the urine culture was obtained from hospital database.

If urine dipstick result was altered, another urine sample was obtained by sterile method, and urine dipstick and culture was done from that sample. Sterile sample was not routinely obtained from patients in whom non-sterile sample dipstick was normal.

In those patients who were considered as failure, the decision of obtaining an urine sample by the alternative technique, or by urethral catheterization was up to the physician who was attending the patient.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

perineal bag

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

Group Type: ACTIVE_COMPARATOR

Perineal bag

Intervention Type: 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.

Bladder stimulation

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

Group Type: EXPERIMENTAL

Bladder stimulation

Intervention Type: 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.

Interventions

Bladder stimulation

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.

Intervention Type: PROCEDURE

Perineal bag

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital del Rio Hortega

OTHER

Sponsor Role: lead

Responsible Party

ROBERTO VELASCO

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PEDHURH-001

Identifier Type: -

Identifier Source: org_study_id