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FILLing Protocols for the Right Bladder Volume at the RIGHT Time (FILLRIGHT)

ConditionBladder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Brest

About this trial

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:

* Quantity A : 1000 ml in 15 minutes * Quantity B : 750 ml in 10 minutes * Quantity C : 500 ml in 5 minutes * Quantity D : 250 ml in 1 minutes

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 :

* A suprapubic ultrasound examination will be performed to assess the bladder filling and to calculate of bladder volume using the standard formula (length × width × height × 0.52) * The Bladder Sensation Scale (BSS) was collected. * 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?"

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult woman

Nulliparous woman

Affiliated with a social security system

Disqualifiers

Pregnant woman

Menopause

History of hysterectomy

Absence of uterus

Trial design

Design model

Single group

Treatments tested in this trial

  • Quantity A

    Other intervention

    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.

  • Quantity B

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Hydratation protocolsExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Bladder volume

The cumulative duration, for each protocol, during which two conditions are met: * Bladder volume greater than 150 ml * Blader Sensation Scale (BSS) score ≤ 2 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. 1. First desire to void - The patient feels the bladder is starting to fill, but it can easily be ignored for a long time. 2. Normal desire to void - The usual feeling that prompts a person to go to the restroom. The urge can be postponed if the person is busy. 3. Strong desire to void / Urgency - The bladder is full. The urge is strong and uncomfortable; it is becoming difficult to delay. 4. Urgent / Painful desire to void - The urge is so intense that it causes discomfort, pain, or fear of leakage. The patient must go immediately.

Time frame
Inclusion

Secondary outcomes

1

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).

Time frame
Inclusion
2

Bladder Sensation Scale progression

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. 1. First desire to void - The patient feels the bladder is starting to fill, but it can easily be ignored for a long time. 2. Normal desire to void - The usual feeling that prompts a person to go to the restroom. The urge can be postponed if the person is busy. 3. Strong desire to void / Urgency - The bladder is full. The urge is strong and uncomfortable; it is becoming difficult to delay. 4. Urgent / Painful desire to void - The urge is so intense that it causes discomfort, pain, or fear of leakage. The patient must go immediately.

Time frame
Inclusion
3

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.

Time frame
Inclusion
4

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).

Time frame
Inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Brest

Lead sponsor

Source ClinicalTrials.gov

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