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

Primary Purpose

Urinary Disorders, Urinary Incontinence, Urinary Bladder Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NIRS recording
Sponsored by
BioSerenity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Urinary Disorders focused on measuring Urodynamic, bladder, detrusor, urinary disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rangueil Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NIRS module

Arm Description

Each patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice.

Outcomes

Primary Outcome Measures

optical measurement of hemoglobin concentrations
concentrations of oxygenated O2Hb, provided from a NIRS module
detrusor pressure measurement (Pdet)
Pdet during filling and emptying of the urodynamic exam
optical measurement of hemoglobin concentrations
concentrations of deoxygenated HHb, provided from NIRS module
optical measurement of hemoglobin concentrations
concentrations of total tHB provided from NIRS module

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2019
Last Updated
November 5, 2021
Sponsor
BioSerenity
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1. Study Identification

Unique Protocol Identification Number
NCT04161716
Brief Title
Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)
Acronym
DETTECH
Official Title
Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioSerenity

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Disorders, Urinary Incontinence, Urinary Bladder Diseases
Keywords
Urodynamic, bladder, detrusor, urinary disorder

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
NIRS module recording
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIRS module
Arm Type
Experimental
Arm Description
Each patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice.
Intervention Type
Device
Intervention Name(s)
NIRS recording
Intervention Description
Patient has a NIRS module during their urodynamic exam.
Primary Outcome Measure Information:
Title
optical measurement of hemoglobin concentrations
Description
concentrations of oxygenated O2Hb, provided from a NIRS module
Time Frame
9 months
Title
detrusor pressure measurement (Pdet)
Description
Pdet during filling and emptying of the urodynamic exam
Time Frame
1 hour
Title
optical measurement of hemoglobin concentrations
Description
concentrations of deoxygenated HHb, provided from NIRS module
Time Frame
9 months
Title
optical measurement of hemoglobin concentrations
Description
concentrations of total tHB provided from NIRS module
Time Frame
9 months
Secondary Outcome Measure Information:
Title
optical measurement of hemoglobin concentrations
Description
concentrations of oxygenated O2Hb, provided from NIRS module
Time Frame
9 months
Title
detrusor pressure measurement (Pdet)
Description
Pdet during filling and emptying of the urodynamic exam
Time Frame
1 hour
Title
optical measurement of hemoglobin concentrations
Description
concentrations of deoxygenated HHb, provided from NIRS module
Time Frame
1 hour
Title
clinical annotations of the doctor performed on the report of the urodynamic exam
Description
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)
Time Frame
1 hour
Title
optical measurement of hemoglobin concentrations
Description
concentrations of total tHB provided from NIRS module
Time Frame
9 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
half of women and half of men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rangueil Hospital
City
Toulouse
ZIP/Postal Code
31400
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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