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

BioSerenity

Status: Completed

Conditions: Urinary Bladder Diseases; Urinary Disorders; Urinary Incontinence

Treatments: Device: NIRS recording

Study type: Interventional

Funder types: Industry

Identifiers

NCT04161716

2019-A02770-57

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

NIRS module

Experimental group

Description:

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

Treatment:

Device: NIRS recording