Uterine AnteflexionFLEXIMIXNCT06669845
Prospective Study of the Variation in the Angle of Anteflexion of the Uterus Before and After Micturition in Nulliparous Women With Uterine Anteversion.
A study testing Ultrasonography, Pelvic in people with Uterine Anteflexion, run by University Hospital, Brest at 1 site in France.
Trial summary
A monocentric, prospective, comparative, and descriptive clinical study examining the uterine anteflexion angle before and after bladder emptying in nulliparous women with uterine anteversion. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Anteflexion
- What is being tested?
- Ultrasonography, Pelvic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 and over;
- Nulliparous ;
- Feeling the need to urinate;
- Affiliated to a Social Security scheme.
Who cannot join
- Pregnant women;
- Desire of pregnancy with conception in progress;
- Primary amenorrhea ;
- Menopause ;
- Previous surgical termination of pregnancy;
- Previous medical abortion;
Show all 11Show fewer
- Previous hysterectomy ;
- Previous conization;
- Absence of uterus;
- Irrepressible need to urinate;
- Inability or refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
A monocentric, prospective, comparative, and descriptive clinical study examining the uterine anteflexion angle before and after bladder emptying in nulliparous women with uterine anteversion. The study aims to assess how bladder fullness affects the anteflexion angle, which may impact the ease of intrauterine device (IUD) insertion. The primary objective is to determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion. Ultrasound measurements will be taken before and after bladder emptying. A secondary objective is to determine the prevalence of uterine anteversion in nulliparous women.
- Conditions
- Uterine Anteflexion
- Being tested
- Ultrasonography, Pelvic
- Keywords
- Uterine anteflexion, Nulliparous women, Full bladder, Ultrasound measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography, PelvicProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography pelvic | Other | Ultrasound measurements before and after bladder emptying Receives: Procedure: Ultrasonography, Pelvic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion.
Difference between mean uterine anteflexion angle full bladder and empty bladder in nulliparous women with uterine anteversion.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 Nov 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine AnteflexionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669845
- Sponsor's protocol ID
- 29BRC24.0124
- Other IDs
- 2024-A01255-42
- Acronym
- FLEXIMIX
- Status last verified
- Feb 2025
- First submitted
- 31 Oct 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Variation in the Angle of Anteflexion of the Uterus Before and After Micturition in Nulliparous Women With Uterine Anteversion.
- ClinicalTrials.gov ID
- NCT06669845
- Acronym / sponsor ID
- FLEXIMIX / 29BRC24.0124
- Conditions
- Uterine Anteflexion
- Keywords
- Uterine anteflexion, Nulliparous women, Full bladder, Ultrasound measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A monocentric, prospective, comparative, and descriptive clinical study examining the uterine anteflexion angle before and after bladder emptying in nulliparous women with uterine anteversion. The study aims to assess how bladder fullness affects the anteflexion angle, which may impact the ease of intrauterine device (IUD) insertion. The primary objective is to determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion. Ultrasound measurements will be taken before and after bladder emptying. A secondary objective is to determine the prevalence of uterine anteversion in nulliparous women.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography pelvic | Other | Procedure: Ultrasonography, PelvicUltrasound measurements before and after bladder emptying |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 and over;
- Nulliparous ;
- Feeling the need to urinate;
- Affiliated to a Social Security scheme.
Key exclusion criteria (11 listed)
- Pregnant women;
- Desire of pregnancy with conception in progress;
- Primary amenorrhea ;
- Menopause ;
- Previous surgical termination of pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonography, PelvicUltrasound 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. | Procedure or surgery | Ultrasonography pelvic |
Primary outcome
To determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion.
Time frame: 1 day
Difference between mean uterine anteflexion angle full bladder and empty bladder in nulliparous women with uterine anteversion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Uterine Anteflexion
Not yet recruiting
Changes in the Angle of Uterine Flexion as the Bladder Fills
Uterine Anteflexion
Recruiting
Bladder Distension for Pain Relief in Patients With Excessive Anteflexion of Uterus Undergoing Office Hysteroscopy
Hysteroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography, Pelvic in people with Uterine Anteflexion, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.