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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Diseases; Urinary Incontinence; Urinary Disorders
• Intervention / Treatment: Device: NIRS recording

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31400
    • Rangueil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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
detrusor pressure measurement (Pdet)	Pdet during filling and emptying of the urodynamic exam	1 hour
optical measurement of hemoglobin concentrations	concentrations of total tHB provided from NIRS module	9 months
optical measurement of hemoglobin concentrations	concentrations of oxygenated O2Hb, provided from NIRS module	9 months
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

Collaborators and Investigators

• Sponsor: BioSerenity

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: bladder; Urodynamic; detrusor; urinary disorder
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder Diseases
• Other Study ID Numbers: 2019-A02770-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No