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

Официальное название

FILLing Protocols for the Right Bladder Volume at the RIGHT Time

Обзор

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?"

Вмешательства

• Другое 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 con
• Другое 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 cond
• Другое 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 condu
• Другое 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 condu

Первичные конечные точки

• Bladder volume [Срок оценки: Inclusion]

Вторичные конечные точки (6)

• Bladder volume progression [Срок оценки: Inclusion]
• Bladder Sensation Scale progression [Срок оценки: Inclusion]
• Correlation between filling rate and the BSS scale [Срок оценки: Inclusion]
• Minimum time [Срок оценки: Inclusion]
• Bladder volume [Срок оценки: Inclusion]
• Acceptability for each protocol [Срок оценки: Inclusion]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Pr Benoit CHIRON — Le Relecq-Kerhuon

Идентификаторы

NCT: NCT07642570 · 29BRC25.0437 - FILLRIGHT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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