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

Urinary Incontinence Clinical Trial

— DETTECH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161716
• Other study ID #: 2019-A02770-57
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: BioSerenity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder Diseases
• Urinary Disorders
• Urinary Incontinence

Intervention

Device:
• NIRS recording
Patient has a NIRS module during their urodynamic exam.

Locations

Country	Name	City	State
France	Rangueil Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
BioSerenity

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optical measurement of hemoglobin concentrations	concentrations of oxygenated O2Hb, provided from a NIRS module	9 months
Primary	detrusor pressure measurement (Pdet)	Pdet during filling and emptying of the urodynamic exam	1 hour
Primary	optical measurement of hemoglobin concentrations	concentrations of deoxygenated HHb, provided from NIRS module	9 months
Primary	optical measurement of hemoglobin concentrations	concentrations of total tHB provided from NIRS module	9 months
Secondary	optical measurement of hemoglobin concentrations	concentrations of oxygenated O2Hb, provided from NIRS module	9 months
Secondary	detrusor pressure measurement (Pdet)	Pdet during filling and emptying of the urodynamic exam	1 hour
Secondary	optical measurement of hemoglobin concentrations	concentrations of deoxygenated HHb, provided from NIRS module	1 hour
Secondary	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
Secondary	optical measurement of hemoglobin concentrations	concentrations of total tHB provided from NIRS module	9 months