NCT04161716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

November 5, 2019

Last Update Submit

November 5, 2021

Conditions

Urinary DisordersUrinary IncontinenceUrinary Bladder Diseases

Keywords

Urodynamicbladderdetrusorurinary disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • optical measurement of hemoglobin concentrations

    9 months

  • detrusor pressure measurement (Pdet)

    1 hour

  • optical measurement of hemoglobin concentrations

    1 hour

  • clinical annotations of the doctor performed on the report of the urodynamic exam

    1 hour

  • optical measurement of hemoglobin concentrations

    9 months

Study Arms (1)

NIRS module

EXPERIMENTAL

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

Device: NIRS recording

Interventions

NIRS recordingDEVICE

Patient has a NIRS module during their urodynamic exam.

NIRS module

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailshalf of women and half of men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Person whose urodynamic evaluation for diagnosis purposes is necessary
  • Male or female ≥ 18 years
  • Person affiliated with a social security scheme
  • ECBU / BU negative

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rangueil Hospital

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder Diseases

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: NIRS module recording
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 13, 2019

Study Start

July 7, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)