Urinary Bladder Diseases, Urinary Disorders, Urinary Incontinence
Conditions
Keywords
Urodynamic, bladder, detrusor, urinary disorder
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.
Interventions
DEVICENIRS recording
Patient has a NIRS module during their urodynamic exam.
Sponsors
BioSerenity
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
NIRS module recording
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| optical measurement of hemoglobin concentrations | 9 months | concentrations of oxygenated O2Hb, provided from a NIRS module |
| detrusor pressure measurement (Pdet) | 1 hour | Pdet during filling and emptying of the urodynamic exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| optical measurement of hemoglobin concentrations | 9 months | concentrations of oxygenated O2Hb, provided from NIRS module |
| detrusor pressure measurement (Pdet) | 1 hour | Pdet during filling and emptying of the urodynamic exam |
| clinical annotations of the doctor performed on the report of the urodynamic exam | 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) |
Countries
France
Outcome results
None listed