Clinical trial NCT04161716: Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)
Official title: Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Disorders
Urinary Incontinence
Urinary Bladder Diseases
Keywords: Urodynamic
bladder
detrusor
urinary disorder
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: NIRS module recording
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed description: The main objective is to detect a urodynamic variation of the detrusor muscle during a contraction.

Eligibility criteria: 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:

* 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
* 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

Primary outcomes:
measure: optical measurement of hemoglobin concentrations
timeFrame: 9 months
measure: detrusor pressure measurement (Pdet)
timeFrame: 1 hour
measure: optical measurement of hemoglobin concentrations
timeFrame: 9 months
measure: optical measurement of hemoglobin concentrations
timeFrame: 9 months
Secondary outcomes:
measure: optical measurement of hemoglobin concentrations
timeFrame: 9 months
measure: detrusor pressure measurement (Pdet)
timeFrame: 1 hour
measure: optical measurement of hemoglobin concentrations
timeFrame: 1 hour
measure: clinical annotations of the doctor performed on the report of the urodynamic exam
timeFrame: 1 hour
measure: optical measurement of hemoglobin concentrations
timeFrame: 9 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Rangueil Hospital
Study officials:
References: