Urinary DisordersDETTECHNCT04161716
Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)
A study testing NIRS recording in people with Urinary Disorders and Urinary Incontinence, run by BioSerenity at 1 site in France.
Trial summary
NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Disorders, Urinary Incontinence, Urinary Bladder Diseases
- What is being tested?
- NIRS recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2020to 30 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person whose urodynamic evaluation for diagnosis purposes is necessary
- Male or female ≥ 18 years
- Person affiliated with a social security scheme
- ECBU / BU negative
Who cannot join
- Minors
- Pregnant or parturient or lactating women
- Refusal of consent
- Contraindications usually provided for the realization of a Urodynamic exam
- Sensory disturbances making the participant insensitive to pain
- Motor or mental disorders that prevent the participant from expressing pain
Show all 13Show fewer
- Behavioral problems that make the participant excessively agitated or aggressive
- Irritation and / or erythema, or open sore in the area covered by the NIRS
- Half-sitting position impossible
- Tattoo or stretch mark in the lower abdomen or pubic area
- External cutaneous or internal scar in the area covered by the NIRS
- Allergy to a component of the textile part of the device: polyamide, cotton, polyester, elastane, silver, other synthetic materials
- Simultaneous participation in another search
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans
NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. This hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue.
In the literature, some studies concerning the use of the NIRS method for the study of urodynamics exist. They seem to show a correlation between the data of the urodynamic assessment and the data obtained with the NIRS method. Certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase.
The aim of the study is to analyze the NIRS signal and find correlation with urodynamic data.
Read the detailed description
The main objective is to detect a urodynamic variation of the detrusor muscle during a contraction.
- Being tested
- NIRS recording
- Keywords
- Urodynamic, bladder, detrusor, urinary disorder
- Medical subject headings
- Urinary Incontinence, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS recordingDevice
Patient has a NIRS module during their urodynamic exam.
| Study group | Role | What they receive |
|---|---|---|
| NIRS module | Experimental | Each patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice. Receives: Device: NIRS recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
optical measurement of hemoglobin concentrations
concentrations of oxygenated O2Hb, provided from a NIRS module
Measured: 9 months
detrusor pressure measurement (Pdet)
Pdet during filling and emptying of the urodynamic exam
Measured: 1 hour
optical measurement of hemoglobin concentrations
concentrations of deoxygenated HHb, provided from NIRS module
Measured: 9 months
optical measurement of hemoglobin concentrations
concentrations of total tHB provided from NIRS module
Measured: 9 months
Secondary outcomes (5)
optical measurement of hemoglobin concentrations
concentrations of oxygenated O2Hb, provided from NIRS module
Measured: 9 months
detrusor pressure measurement (Pdet)
Pdet during filling and emptying of the urodynamic exam
Measured: 1 hour
optical measurement of hemoglobin concentrations
concentrations of deoxygenated HHb, provided from NIRS module
Measured: 1 hour
clinical annotations of the doctor performed on the report of the urodynamic exam
Normality of detrusor function (YES/NO), hyperactive detrusor function (YES/NO) , hypoactive detrusor function (YES/NO).
Criteria assessed by the investigator by a response (yes/No)
Measured: 1 hour
optical measurement of hemoglobin concentrations
concentrations of total tHB provided from NIRS module
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start7 Jul 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary DisordersStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- NIRS module recording
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSerenity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161716
- Sponsor's protocol ID
- 2019-A02770-57
- Acronym
- DETTECH
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2019
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans
- ClinicalTrials.gov ID
- NCT04161716
- Acronym / sponsor ID
- DETTECH / 2019-A02770-57
- Keywords
- Urodynamic, bladder, detrusor, urinary disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BioSerenityIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Nov 2019 (actual)
- 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.
NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. This hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue.
In the literature, some studies concerning the use of the NIRS method for the study of urodynamics exist. They seem to show a correlation between the data of the urodynamic assessment and the data obtained with the NIRS method. Certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase.
The aim of the study is to analyze the NIRS signal and find correlation with urodynamic data.
Detailed description
The main objective is to detect a urodynamic variation of the detrusor muscle during a contraction.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- NIRS module recording
| Arm | Type | Receives |
|---|---|---|
| NIRS module | Experimental | Device: NIRS recordingEach patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Person whose urodynamic evaluation for diagnosis purposes is necessary
- Male or female ≥ 18 years
- Person affiliated with a social security scheme
- ECBU / BU negative
Key exclusion criteria (13 listed)
- Minors
- Pregnant or parturient or lactating women
- Refusal of consent
- Contraindications usually provided for the realization of a Urodynamic exam
- Sensory disturbances making the participant insensitive to pain
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 |
|---|---|---|
| NIRS recordingPatient has a NIRS module during their urodynamic exam. | Device | NIRS module |
Primary outcome
optical measurement of hemoglobin concentrations
Time frame: 9 months
concentrations of oxygenated O2Hb, provided from a NIRS module
detrusor pressure measurement (Pdet)
Time frame: 1 hour
Pdet during filling and emptying of the urodynamic exam
optical measurement of hemoglobin concentrations
Time frame: 9 months
concentrations of deoxygenated HHb, provided from NIRS module
optical measurement of hemoglobin concentrations
Time frame: 9 months
concentrations of total tHB provided from NIRS module
5 secondary outcomes
optical measurement of hemoglobin concentrations
Time frame: 9 months
detrusor pressure measurement (Pdet)
Time frame: 1 hour
optical measurement of hemoglobin concentrations
Time frame: 1 hour
clinical annotations of the doctor performed on the report of the urodynamic exam
Time frame: 1 hour
optical measurement of hemoglobin concentrations
Time frame: 9 months
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 8 Nov 2021.
- 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.
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?
A study testing NIRS recording in people with Urinary Disorders and Urinary Incontinence, run by BioSerenity 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 4 inclusion and 13 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 8 Nov 2021. 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?
optical measurement of hemoglobin concentrations (time frame: 9 months). The study lists 4 primary outcomes in all. 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 8 Nov 2021.