Urinary Tract InfectionNCT02569944
Feasibility of Bladder Stimulation in Infants
A study testing Bladder stimulation and Perineal bag in people with Urinary Tract Infection, run by Hospital del Rio Hortega.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Bladder stimulation and Perineal bag
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Evaluation of Feasibility of Urine Collection Using Perineal Bag Versus Bladder Stimulation in Infants Less Than 12 Months Old
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.
Read the 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
- Being tested
- Bladder stimulation, Perineal bag
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder stimulationProcedure or surgery
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.
Perineal bagProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| perineal bag | Active comparator | Perineal bag was placed in infants to collect an urine sample. Receives: Procedure: Perineal bag |
| Bladder stimulation | Experimental | Bladder stimulation technique was used in infants of this arm to obtain an urine sample Receives: Procedure: Bladder stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5400 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROBERTO VELASCO, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569944
- Sponsor's protocol ID
- PEDHURH-001
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility of Urine Collection Using Perineal Bag Versus Bladder Stimulation in Infants Less Than 12 Months Old
- ClinicalTrials.gov ID
- NCT02569944
- Acronym / sponsor ID
- PEDHURH-001
- Conditions
- Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perineal bag | Active comparator | Procedure: Perineal bagPerineal bag was placed in infants to collect an urine sample. |
| Bladder stimulation | Experimental | Procedure: Bladder stimulationBladder stimulation technique was used in infants of this arm to obtain an urine sample |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder stimulationPatients 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. | Procedure or surgery | Bladder stimulation |
| Perineal bagPatients 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. | Procedure or surgery | perineal bag |
Primary outcome
Urine sample collection
Time frame: 5400 seconds
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder stimulation and Perineal bag in people with Urinary Tract Infection, run by Hospital del Rio Hortega.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine sample collection (time frame: 5400 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.