The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women. (FLEXIMIX 2)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Uterine Anteflexion; Parous Women

Treatments: Procedure: ultrasonography, pelvic

Study type: Interventional

Funder types: Other

Identifiers

NCT07084766

29BRC25.0036

ID RCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Transabdominal ultrasonography

Other group

Description:

Ultrasound measurements before and after bladder emptying

Treatment:

Procedure: ultrasonography, pelvic