Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

8. Juni 2026 aktualisiert von: 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?"

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Frankreich
      • Le Relecq-Kerhuon, Frankreich, 2948
        • Pr Benoit CHIRON
        • Unterermittler:
          • Paul AUJOULAT, Dr
        • Kontakt:
        • Hauptermittler:
          • Benoit CHIRON, Pr

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Sonstiges: 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.

Sonstiges: 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.

Sonstiges: 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.

Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bladder volume
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bladder volume progression
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Brest

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Mai 2028

Studienabschluss (Geschätzt)

1. August 2028

Studienanmeldedaten

Zuerst eingereicht

8. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 29BRC25.0437 - FILLRIGHT

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren