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NCT Number: NCT07642570

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

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?"

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pr Benoit CHIRON

Le Relecq-Kerhuon, 2948, France

Location contact

Benoit CHIRON, Pr

CONTACT

[email protected]

02 98 40 19 21

Benoit CHIRON, Pr

PRINCIPAL_INVESTIGATOR

Paul AUJOULAT, Dr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult woman
  • Nulliparous woman
  • Affiliated with a social security system

Exclusion criteria

  • Pregnant woman
  • Menopause
  • History of hysterectomy
  • Absence of uterus
  • Symptoms of urinary tract infection (macroscopic hematuria, burning during urination, pollakiuria)
  • Overactive bladder defined by the clinical question: "Do you have an urgent need to urinate, difficult to control, sometimes resulting in leakage?"
  • Under legal protection (guardianship, conservatorship)
  • Refusal to participate

Treatment and study plan

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.

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.

Primary outcomes

  1. Bladder volume

    Time frame: Inclusion

    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.

    • First desire to void - The patient feels the bladder is starting to fill, but it can easily be ignored for a long time.
    • 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.
    • Strong desire to void / Urgency - The bladder is full. The urge is strong and uncomfortable; it is becoming difficult to delay.
    • Urgent / Painful desire to void - The urge is so intense that it causes discomfort, pain, or fear of leakage. The patient must go immediately.

Secondary outcomes

  1. Bladder volume progression

    Time frame: Inclusion

    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).

  2. Bladder Sensation Scale progression

    Time frame: Inclusion

    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.

    • First desire to void - The patient feels the bladder is starting to fill, but it can easily be ignored for a long time.
    • 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.
    • Strong desire to void / Urgency - The bladder is full. The urge is strong and uncomfortable; it is becoming difficult to delay.
    • Urgent / Painful desire to void - The urge is so intense that it causes discomfort, pain, or fear of leakage. The patient must go immediately.
  3. Correlation between filling rate and the BSS scale

    Time frame: Inclusion

    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.

  4. Minimum time

    Time frame: Inclusion

    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).

  5. Bladder volume

    Time frame: Inclusion

    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.

  6. Acceptability for each protocol

    Time frame: Inclusion

    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?"

Study contacts

Contact information is provided by the study sponsor or research team.

Benoit CHIRON, Pr

CONTACT

[email protected]

06.98.34.71.01

Tiphaine MENEZ

CONTACT

[email protected]

02.30.33.84.60

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

FILLing Protocols for the Right Bladder Volume at the RIGHT Time

Acronym: FILLRIGHT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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