Uterine AnteflexionFLEXIMIX 2NCT07084766
The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.
A study testing ultrasonography, pelvic in people with Uterine Anteflexion and Parous Women, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Anteflexion, Parous Women
- 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
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2025to 30 Oct 2025
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women
- Parous
- Experiencing the need to urinate
- Affiliated with a social security scheme or equivalent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Uterine Anteflexion, Parous Women
- Being tested
- ultrasonography, pelvic
- Keywords
- uterine anteflexion, nulliparous women, full bladder, angle of anteflexion or retroflexion of the uterus, 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 |
|---|---|---|
| Transabdominal ultrasonography | 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.
Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women
To determine the difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women
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 posted25 Jul 2025
- Study start25 Sep 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
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
- 200 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
- NCT07084766
- Sponsor's protocol ID
- 29BRC25.0036
- Other IDs
- ID RCB
- Acronym
- FLEXIMIX 2
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.
- ClinicalTrials.gov ID
- NCT07084766
- Acronym / sponsor ID
- FLEXIMIX 2 / 29BRC25.0036
- Conditions
- Uterine Anteflexion, Parous Women
- Keywords
- uterine anteflexion, nulliparous women, full bladder, angle of anteflexion or retroflexion of the uterus, ultrasound measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 25 Jul 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transabdominal ultrasonography | Other | Procedure: ultrasonography, pelvicUltrasound measurements before and after bladder emptying |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult women
- Parous
- Experiencing the need to urinate
- Affiliated with a social security scheme or equivalent
Key exclusion criteria (8 listed)
- Pregnant women
- Desire for pregnancy with ongoing conception process
- Age > 65 years
- History of hysterectomy
- History of conization
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 | Transabdominal ultrasonography |
Primary outcome
Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women
Time frame: 1 day
To determine the difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women
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 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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 and Parous Women, 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 8 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 19 Dec 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?
Difference between the mean angles of uterine anteflexion and retroflexion with a full and empty bladder in parous women (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 19 Dec 2025.