NCT04161716

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: BioSerenity · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Disorders
• Urinary Incontinence
• Urinary Bladder Diseases

Interventions

Type	Name	Description
DEVICE	NIRS recording	Patient has a NIRS module during their urodynamic exam.

Timeline

• Start date: 2020-07-07
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2019-11-13
• Last updated: 2021-11-08

Locations

1 site across 1 country: France