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

Study Overview
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Brief Summary
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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
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The main objective is to detect a urodynamic variation of the detrusor muscle during a contraction.

Official Title
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Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans

Conditions
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Urinary Disorders, Urinary Incontinence, Urinary Bladder Diseases

Intervention / Treatment
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* Device: NIRS recording


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: NIRS module recording
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRS module<br>Each patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice. | Device: NIRS recording<br>* Patient has a NIRS module during their urodynamic exam.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optical measurement of hemoglobin concentrations | concentrations of oxygenated O2Hb, provided from a NIRS module | 9 months | 
| detrusor pressure measurement (Pdet) | Pdet during filling and emptying of the urodynamic exam | 1 hour | 
| optical measurement of hemoglobin concentrations | concentrations of deoxygenated HHb, provided from NIRS module | 9 months | 
| optical measurement of hemoglobin concentrations | concentrations of total tHB provided from NIRS module | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optical measurement of hemoglobin concentrations | concentrations of oxygenated O2Hb, provided from NIRS module | 9 months | 
| detrusor pressure measurement (Pdet) | Pdet during filling and emptying of the urodynamic exam | 1 hour | 
| optical measurement of hemoglobin concentrations | concentrations of deoxygenated HHb, provided from NIRS module | 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) | 1 hour | 
| optical measurement of hemoglobin concentrations | concentrations of total tHB provided from NIRS module | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urodynamic, bladder, detrusor, urinary disorder