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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07084766
Acronym
FLEXIMIX 2
Enrollment
200
Registered
2025-07-25
Start date
2025-09-25
Completion date
2025-10-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parous Women, Uterine Anteflexion

Keywords

uterine anteflexion, nulliparous women, full bladder, angle of anteflexion or retroflexion of the uterus, ultrasound measurements

Brief summary

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.

Interventions

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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women1 dayTo determine the difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026