BladderFILLRIGHTNCT07642570
FILLing Protocols for the Right Bladder Volume at the RIGHT Time (FILLRIGHT)
A study testing Quantity A, Quantity B and Quantity C in people with Bladder, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder
- What is being tested?
- Quantity A, Quantity B and Quantity C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult woman
- Nulliparous woman
- Affiliated with a social security system
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Pr Benoit CHIRON
Le Relecq-Kerhuon, 2948
Benoit CHIRON, Pr, 02 98 40 19 21, benoitchiron@yahoo.fr
Benoit CHIRON, Pr
About this study
Official title: 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.
Read more
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?"
- Conditions
- Bladder
- Being tested
- Quantity A, Quantity B, Quantity C, Quantity D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantity AOther
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 BOther
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 COther
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 DOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydratation protocols | Experimental | 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. Receives: Other: Quantity A; Other: Quantity B; Other: Quantity C; Other: Quantity D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: Inclusion
Secondary outcomes (6)
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).
Measured: Inclusion
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.
- 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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?"
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BladderStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642570
- Sponsor's protocol ID
- 29BRC25.0437 - FILLRIGHT
- Acronym
- FILLRIGHT
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FILLing Protocols for the Right Bladder Volume at the RIGHT Time
- ClinicalTrials.gov ID
- NCT07642570
- Acronym / sponsor ID
- FILLRIGHT / 29BRC25.0437 - FILLRIGHT
- Conditions
- Bladder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydratation protocols | Experimental | Other: Quantity A, Other: Quantity B, Other: Quantity C, Other: Quantity DWoman 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult woman
- Nulliparous woman
- Affiliated with a social security system
Key exclusion criteria (8 listed)
- Pregnant woman
- Menopause
- History of hysterectomy
- Absence of uterus
- Symptoms of urinary tract infection (macroscopic hematuria, burning during urination, pollakiuria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantity AWoman 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 | Hydratation protocols |
| Quantity BWoman 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 | Hydratation protocols |
| Quantity CWoman 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 | Hydratation protocols |
| Quantity DWoman 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. | Other | Hydratation protocols |
Primary outcome
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.
6 secondary outcomes
Bladder volume progression
Time frame: Inclusion
Bladder Sensation Scale progression
Time frame: Inclusion
Correlation between filling rate and the BSS scale
Time frame: Inclusion
Minimum time
Time frame: Inclusion
Bladder volume
Time frame: Inclusion
Acceptability for each protocol
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantity A, Quantity B and Quantity C in people with Bladder, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit CHIRON, Pr (06.98.34.71.01, benoitchiron@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder volume (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.