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CompletedNCT04161716DETTECHUpdated Nov 8, 2021

Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)

An interventional study of NIRS recording in Urinary Disorders, Urinary Incontinence and Urinary Bladder Diseases, sponsored by BioSerenity. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.

Sponsored by BioSerenity · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Urinary Disorders
  • Urinary Incontinence
  • Urinary Bladder Diseases

Keywords

  • Urodynamic
  • bladder
  • detrusor
  • urinary disorder
03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's enrollment of 40 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

BioSerenity is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Person whose urodynamic evaluation for diagnosis purposes is necessary
  • Male or female ≥ 18 years
  • Person affiliated with a social security scheme
  • ECBU / BU negative

Exclusion criteria

Exclusion Criteria:

  • Minors
  • Pregnant or parturient or lactating women
  • Refusal of consent
  • 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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    NIRS module

    Each patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice.

    Device: NIRS recording

Interventions

  • DeviceNIRS recording

    Patient has a NIRS module during their urodynamic exam.

06

What researchers measure

Primary outcomes

  1. optical measurement of hemoglobin concentrations

    concentrations of oxygenated O2Hb, provided from a NIRS module

    Time frame: 9 months

  2. detrusor pressure measurement (Pdet)

    Pdet during filling and emptying of the urodynamic exam

    Time frame: 1 hour

  3. optical measurement of hemoglobin concentrations

    concentrations of deoxygenated HHb, provided from NIRS module

    Time frame: 9 months

  4. optical measurement of hemoglobin concentrations

    concentrations of total tHB provided from NIRS module

    Time frame: 9 months

Secondary outcomes

  1. optical measurement of hemoglobin concentrations

    concentrations of oxygenated O2Hb, provided from NIRS module

    Time frame: 9 months

  2. detrusor pressure measurement (Pdet)

    Pdet during filling and emptying of the urodynamic exam

    Time frame: 1 hour

  3. optical measurement of hemoglobin concentrations

    concentrations of deoxygenated HHb, provided from NIRS module

    Time frame: 1 hour

  4. 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)

    Time frame: 1 hour

  5. optical measurement of hemoglobin concentrations

    concentrations of total tHB provided from NIRS module

    Time frame: 9 months

07

Study locations

1 site
  • Rangueil Hospital
    Toulouse, 31400, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Sep 2021, 14 months.

Of 63 industry-sponsored interventional studies with no phase under Urinary Incontinence, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 21. This study's 14 months is above that.

Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2019
First posted
Nov 13, 2019
StartActual
Jul 7, 2020
Primary completionActual
Sep 30, 2021
CompletionActual
Sep 30, 2021
Last update
Nov 8, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04161716
Lead sponsor
BioSerenity
Responsible party
Sponsor
First posted
Nov 13, 2019
Start date
Jul 7, 2020
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Nov 8, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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