Skip to main content
OpenTrials
Completed

NCT Number: NCT07084766

The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.

Intrauterine devices (IUDs) account for approximately 25% of contraceptive methods used in France. However, their insertion can be painful for patients and challenging for practitioners, particularly due to the passage through the cervix and the uterine flexion angle. An interventional study conducted by Cameron in 2013 examined the impact of bladder filling on the ease of IUD insertion. The results did not show a significant benefit, suggesting that a full bladder does not necessarily improve the procedure. An ongoing study, FLEXIMIX, led by the coordinator, explores the variation in the uterine flexion angle based on bladder filling in 250 nulliparous women. Preliminary results indicate a strong influence of bladder filling on the flexion angle. Additionally, the Valsalva maneuver, which involves increasing intra-abdominal pressure by forceful exhalation against a closed glottis, has been shown in two recent studies to facilitate gynecological interventions by improving cervical passage, thereby reducing the need for invasive instruments such as the tenaculum.What happens in parous women and during the Valsalva maneuver remains to be explored.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brest

Brest, Finistere, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult women
  • Parous
  • Experiencing the need to urinate
  • Affiliated with a social security scheme or equivalent

Exclusion criteria

  • Pregnant women
  • Desire for pregnancy with ongoing conception process
  • Age > 65 years
  • History of hysterectomy
  • History of conization
  • Childbirth < 6 months
  • Irrepressible need to urinate
  • Inability or refusal to participate in the study

Treatment and study plan

ultrasonography, pelvic

Procedure

Ultrasound measurements will be taken before and after bladder emptying. The axes of the uterine body, cervix and vagina will be marked out by tracing the 3 corresponding lines on the image.

Primary outcomes

  1. Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women

    Time frame: 1 day

    To determine the difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: FLEXIMIX 2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.