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

8 giugno 2026 aggiornato da: 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?"

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Le Relecq-Kerhuon, Francia, 2948
        • Pr Benoit CHIRON
        • Sub-investigatore:
          • Paul AUJOULAT, Dr
        • Contatto:
        • Investigatore principale:
          • Benoit CHIRON, Pr

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.

Altro: 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.

Altro: 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.

Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bladder volume
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bladder volume progression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Brest

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 agosto 2028

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 29BRC25.0437 - FILLRIGHT

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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