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

2026년 6월 8일 업데이트: 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?"

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Le Relecq-Kerhuon, 프랑스, 2948
        • Pr Benoit CHIRON
        • 부수사관:
          • Paul AUJOULAT, Dr
        • 연락하다:
        • 수석 연구원:
          • Benoit CHIRON, Pr

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 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.

다른: 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.

다른: 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.

다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Bladder volume
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Bladder volume progression
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Brest

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 5월 1일

연구 완료 (추정된)

2028년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 8일

QC 기준을 충족하는 최초 제출

2026년 6월 8일

처음 게시됨 (실제)

2026년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 8일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 29BRC25.0437 - FILLRIGHT

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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