Spina BifidaBUHD-SPINANCT02852317
Urinary Markers of Detrusor Overactivity in Spina Bifida Patients
An observational study of Spina Bifida and Multiple Sclerosis, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spina Bifida, Multiple Sclerosis, Spinal Cord Injury
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2015to 17 Jul 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with an urodynamic examination scheduled
Who may be able to join
- Study arm:
- Spina bifida patient
- Seen consecutively in outpatient clinics
- Age > 18 years-old
- Control arm:
- Patients with multiple sclerosis or spinal cord injury or overactive bladder
Show all 9Show fewer
- Seen consecutively in urodynamics
- with lower urinary tract symptoms
- Age > 18 years-old
Who cannot join
- Positive urine culture
- History of urologic neoplasms
- History of interstitial cystitis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients.
- Medical subject headings
- Spinal Dysraphism, Multiple Sclerosis, Spinal Cord Injuries, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spina bifida patient | Not described | |
| Patients with multiple sclerosis | Not described | |
| Patients with spinal cord injury | Not described | |
| Patients with overactive bladder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of urinary markers will be evaluated by area under the curve (AUC)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start16 Mar 2015
- Primary completion29 Mar 2017
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852317
- Sponsor's protocol ID
- 35RC14_8805
- Acronym
- BUHD-SPINA
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 11 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Markers of Detrusor Overactivity in Spina Bifida Patients
- ClinicalTrials.gov ID
- NCT02852317
- Acronym / sponsor ID
- BUHD-SPINA / 35RC14_8805
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 2 Aug 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 purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spina bifida patient | – | – |
| Patients with multiple sclerosis | – | – |
| Patients with spinal cord injury | – | – |
| Patients with overactive bladder | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with an urodynamic examination scheduled
Key inclusion criteria (9 listed)
- Spina bifida patient
- Seen consecutively in outpatient clinics
- Age > 18 years-old
- Patients with multiple sclerosis or spinal cord injury or overactive bladder
- Seen consecutively in urodynamics
Key exclusion criteria (3 listed)
- Positive urine culture
- History of urologic neoplasms
- History of interstitial cystitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of urinary markers will be evaluated by area under the curve (AUC)
Time frame: through study completion, an average of 1 year
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 11 Sep 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida and Multiple Sclerosis, run by Rennes University Hospital 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 9 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 11 Sep 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?
Accuracy of urinary markers will be evaluated by area under the curve (AUC) (time frame: through study completion, an average of 1 year). 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 11 Sep 2018.