Changes in the Angle of Uterine Flexion as the Bladder Fills

NCT07803627 | Not Yet Recruiting

• 1 other identifier: 29BRC25.0436
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate how bladder filling affects the uterine flexion angle in adult nulliparous women with a uterine flexion angle \<90° when the bladder is empty. The main questions it aims to answer are: How does the uterine flexion angle change as bladder volume increases? What bladder volume is needed to obtain a uterine flexion angle \>90°? Participants will: Drink 600 mL of water following a standardized protocol. Undergo repeated suprapubic ultrasound measurements of bladder volume and uterine flexion angle. Remain under observation until urination or for a maximum of 4 hours. No comparison group is included in this study.

Conditions

Uterine Anteflexion

Keywords

Uterine anteflexion; Nulliparous women; Bladder filling; Ultrasound measurements

Outcome Measures

Primary Outcomes (1)

• Uterine Flexion Angle Measured at Different Bladder Volumes in Nulliparous Women With an Anteverted Uterus and Baseline Uterine Flexion Angle <90°

  The relationship between bladder volume and the angle of uterine flexion, as determined from repeated ultrasound measurements in the participants.

  4 hours

Study Arms (1)

Ultrasonography pelvic

OTHER

Repeated ultrasound measurements, alternating between volume and angle of flexion, immediately following a hydration protocol and then bladder emptying.

Procedure: Ultrasonography, Pelvic

Interventions

Ultrasonography, Pelvic PROCEDURE

Repeated ultrasound measurements, alternating between volume and angle of flexion, immediately following a hydration protocol and then bladder emptying.

Ultrasonography pelvic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult woman
• Nulliparous
• Registered with a social security scheme
• Uterine flexion angle \< 90°, empty bladder

You may not qualify if:

• Pregnant woman
• Woman wishing to become pregnant and currently trying to conceive
• Primary amenorrhoea
• Menopause
• History of surgical termination of pregnancy
• History of medical termination of pregnancy
• History of hysterectomy
• History of conisation
• Absence of the uterus
• Symptoms of urinary tract infection (gross haematuria, burning on urination, frequent urination)
• Under legal guardianship (curatorship, trusteeship)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Benoit CHIRON

Le Relecq-Kerhuon, 29480, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Benoit CHIRON, MD

CONTACT

02 98 40 19 21; benoitchiron@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 3, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)