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The goal of this clinical trial is to compare evaluation of oral hydration protocols for the right optimal bladder filling prior to pelvic ultrasound.
The main question it aims to answer is which quantity of water should patiente drink before a pelvic ultrasound.
Woman participants will drink 4 differents quantity of water over 4 differents days:
The order of the hydration protocols will be randomized.
All procedures are performed in the same way:
Before ingestion of water, the patient should urinate band (the volumen will be measured) an an ultrasound examination will be performed to assess the residual post-void volume
The patiente drinks water and the time was collected
Every 5 minutes during the procedure :
When the score to BBS reaches 3, the procedure should be stopped and the patiente should urinate band (the volumen will be measured). Then a last ultrasound examination will be performed.
After each procedure, the patiente answer at this question: "On a scale from 1 (very poor) to 10 (excellent), how would you rate the acceptability of ingesting the required hydration volume?"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydratation protocols | Experimental | Woman participants will drink 4 differents quantity of water over 4 differents days:
The order of the hydration protocols will be randomized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantity A | Other | Woman participants will drink 1000 ml in 15 minutes. Before ingestion of water, an ultrasound examination will be performed to assess the residual post-void volume. Before ingestion of water, a suprapubic ultrasound examination will be performed to assess the bladder filling, and calculation of bladder volume using the standard formula (length × width × height × 0.52). During ultrasound examination, a self-assessment of urinary sensitivity using the Bladder Sensitivity Scale (BSS) will be conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder volume | The cumulative duration, for each protocol, during which two conditions are met:
Each score represents what the patient feels at a specific moment: 0: No sensation - The bladder is empty, or the patient feels absolutely nothing.
| Inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder volume progression | For each protocol, the average curve of bladder volume progression will plott. A suprapubic ultrasound examination will be performed every 5 minutes during the procedure to calculate of bladder volume using the standard formula (length × width × height × 0.52). | Inclusion |
| Bladder Sensation Scale progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benoit CHIRON, Pr | Contact | 06.98.34.71.01 | benoitchiron@yahoo.fr | |
| Tiphaine MENEZ | Contact | 02.30.33.84.60 | tiphaine.menez@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr Benoit CHIRON | Le Relecq-Kerhuon | 2948 | France |
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| Quantity B | Other | Woman participants will drink 750 ml in 10 minutes. Before ingestion of water, an ultrasound examination will be performed to assess the residual post-void volume. Before ingestion of water, a suprapubic ultrasound examination will be performed to assess the bladder filling, and calculation of bladder volume using the standard formula (length × width × height × 0.52). During ultrasound examination, a self-assessment of urinary sensitivity using the Bladder Sensitivity Scale (BSS) will be conducted. |
|
| Quantity C | Other | Woman participants will drink 500 ml in 5 minutes. Before ingestion of water, an ultrasound examination will be performed to assess the residual post-void volume. Before ingestion of water, a suprapubic ultrasound examination will be performed to assess the bladder filling, and calculation of bladder volume using the standard formula (length × width × height × 0.52). During ultrasound examination, a self-assessment of urinary sensitivity using the Bladder Sensitivity Scale (BSS) will be conducted. |
|
| Quantity D | Other | Woman participants will drink 250 ml in 1 minutes. Before ingestion of water, an ultrasound examination will be performed to assess the residual post-void volume. Before ingestion of water, a suprapubic ultrasound examination will be performed to assess the bladder filling, and calculation of bladder volume using the standard formula (length × width × height × 0.52). During ultrasound examination, a self-assessment of urinary sensitivity using the Bladder Sensitivity Scale (BSS) will be conducted. |
|
For each protocol, the average curve of Bladder Sensation Scale (BSS) progression will plott. The BSS is a medical tool used to evaluate and quantify how a patient perceives bladder fullness. The scale typically ranges from 0 to 4 . Each score represents what the patient feels at a specific moment: 0: No sensation - The bladder is empty, or the patient feels absolutely nothing.
|
| Inclusion |
| Correlation between filling rate and the BSS scale | Correlation between filling rate (a suprapubic ultrasound examination will be performed to assess the bladder filling every 5 minutes during the procedure) and the Bladder Sensation Scale will be assessed at the same time. | Inclusion |
| Minimum time | Determination, for each protocol, of the minimum time required to achieve a bladder volume ≥ 150 ml in all participants (a suprapubic ultrasound examination will be performed to assess the bladder filling every 5 minutes during the procedure). | Inclusion |
| Bladder volume | Absolute and relative difference between the actual urine volume and the ultrasound-estimated volume just before voiding at the end of the procedure, adjusted after ultrasound estimation of post-void residual urine. Before ingestion of water, the patient should urinate band (the volumen will be measured) an an ultrasound examination will be performed to assess the residual post-void volume. When the BSS score reaches 3, the procedure should be stopped and the patiente should urinate band (the volumen will be measured). Then a last ultrasound examination will be performed. | Inclusion |
| Acceptability for each protocol | Cumulative acceptability score for each protocol on a scale from 1 to 10. Response to the question: "On a scale from 1 (very poor) to 10 (excellent), how would you rate the acceptability of ingesting the required hydration volume?" | Inclusion |