Prospective Study of the Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.

Not Applicable

Not yet recruiting

• Conditions: Uterine Anteflexion; Parous Women

• Registration Number: NCT07084766
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Study Start: 2025-09-01
• Primary Completion: 2026-07-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the variation in the uterine flexion angle before and after micturition in parous women."	1 day	To determine the difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women

Trial Locations

Locations (1)

CHU Brest; 🇫🇷 Brest, Finistere, France