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Clinical Trials/NCT07642570
NCT07642570Not yet recruitingNot Applicable

FILLing Protocols for the Right Bladder Volume at the RIGHT Time

University Hospital, Brest1 site in 1 country20 target enrollmentStarted: September 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
20
Locations
1

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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