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

NCT ID: NCT07084766

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2025-10-30

Brief Summary

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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

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Conditions

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Uterine Anteflexion Parous Women

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Transabdominal ultrasonography

Ultrasound measurements before and after bladder emptying

Group Type OTHER

ultrasonography, pelvic

Intervention Type 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.

Interventions

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ultrasonography, pelvic

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Brest

Brest, Finistere, France

Site Status

Countries

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France

Other Identifiers

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ID RCB

Identifier Type: OTHER

Identifier Source: secondary_id

29BRC25.0036

Identifier Type: -

Identifier Source: org_study_id