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

June 8, 2026 updated by: University Hospital, Brest

FILLing Protocols for the Right Bladder Volume at the RIGHT Time

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?"

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Le Relecq-Kerhuon, France, 2948
        • Pr Benoit CHIRON
        • Sub-Investigator:
          • Paul AUJOULAT, Dr
        • Contact:
        • Principal Investigator:
          • Benoit CHIRON, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydratation protocols

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.
Other: Quantity A

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.

Other: Quantity B

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.

Other: Quantity C

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.

Other: Quantity D

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

  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.
Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Inclusion
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.

  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.
Inclusion
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.
Inclusion
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).
Inclusion
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.
Inclusion
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?"
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 29BRC25.0437 - FILLRIGHT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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