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

Not Applicable

Completed

• Conditions: Urinary Bladder Diseases; Urinary Incontinence; Urinary Disorders

• Registration Number: NCT04161716
• Lead Sponsor: BioSerenity

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.

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Study Start: 2020-07-07
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
optical measurement of hemoglobin concentrations	9 months	concentrations of total tHB provided from NIRS module
detrusor pressure measurement (Pdet)	1 hour	Pdet during filling and emptying of the urodynamic exam

Secondary Outcome Measures

Name	Time	Method
detrusor pressure measurement (Pdet)	1 hour	Pdet during filling and emptying of the urodynamic exam
optical measurement of hemoglobin concentrations	9 months	concentrations of total tHB provided from NIRS module
clinical annotations of the doctor performed on the report of the urodynamic exam	1 hour	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)

Trial Locations

Locations (1)

Rangueil Hospital; 🇫🇷 Toulouse, France