Urinary RetentionStiVeNNCT02749188
Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infant Who Have Not Acquired Walking
A study testing Bladder stimulation in people with Urinary Retention, run by Fondation Lenval at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Bladder stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to 10 Oct 2017
- 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 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking
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.
Read more
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.
Read the detailed 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
- Conditions
- Urinary Retention
- Being tested
- Bladder stimulation
- Keywords
- Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder stimulationOther
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
| Study group | Role | What they receive |
|---|---|---|
| bladder stimulation | Other | 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. Receives: Other: Bladder stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During baseline at time 0
Secondary outcomes (3)
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)
Measured: During baseline at time 0
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
Measured: During baseline at time 0
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
Measured: During baseline after 2 attemps of bladder stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startOct 2014
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine TRAN, MD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749188
- Sponsor's protocol ID
- 14-HPNCL-07
- Acronym
- StiVeN
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking
- ClinicalTrials.gov ID
- NCT02749188
- Acronym / sponsor ID
- StiVeN / 14-HPNCL-07
- Conditions
- Urinary Retention
- Keywords
- Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 22 Apr 2016 (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.
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.
Detailed 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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bladder stimulation | Other | Other: Bladder stimulationBladder 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 stimulationBladder 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 | Other | bladder stimulation |
Primary outcome
Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking
Time frame: During baseline at time 0
• 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.
3 secondary outcomes
evaluation period of urine collection
Time frame: During baseline at time 0
Evaluation of the tolerance of the infant
Time frame: During baseline at time 0
alternative of the urine sample
Time frame: During baseline after 2 attemps of bladder stimulation
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 31 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Antoine TRAN, MD principal investigator
Fondation Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder stimulation in people with Urinary Retention, run by Fondation Lenval at 1 site in France.
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 7 inclusion and 5 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking (time frame: During baseline at time 0). 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 31 Jul 2018.