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NCT Number: NCT04161716

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIRS recording

Device

Patient has a NIRS module during their urodynamic exam.

Primary outcomes

  1. optical measurement of hemoglobin concentrations

    Time frame: 9 months

    concentrations of oxygenated O2Hb, provided from a NIRS module

  2. detrusor pressure measurement (Pdet)

    Time frame: 1 hour

    Pdet during filling and emptying of the urodynamic exam

  3. optical measurement of hemoglobin concentrations

    Time frame: 9 months

    concentrations of deoxygenated HHb, provided from NIRS module

  4. optical measurement of hemoglobin concentrations

    Time frame: 9 months

    concentrations of total tHB provided from NIRS module

Secondary outcomes

  1. optical measurement of hemoglobin concentrations

    Time frame: 9 months

    concentrations of oxygenated O2Hb, provided from NIRS module

  2. detrusor pressure measurement (Pdet)

    Time frame: 1 hour

    Pdet during filling and emptying of the urodynamic exam

  3. optical measurement of hemoglobin concentrations

    Time frame: 1 hour

    concentrations of deoxygenated HHb, provided from NIRS module

  4. clinical annotations of the doctor performed on the report of the urodynamic exam

    Time frame: 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)

  5. optical measurement of hemoglobin concentrations

    Time frame: 9 months

    concentrations of total tHB provided from NIRS module

Sponsors and collaborators

Lead sponsor

BioSerenity

Industry

Registry information

Official study title

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

Acronym: DETTECH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2019
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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