Pelvic Floor DisordersMI-IRMNCT04319653
Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
A study testing Dynamic pelvic MRI with intravaginal probe with pressure sensor in people with Pelvic Floor Disorders, run by University Hospital, Lille at 1 site in France.
Trial summary
The conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). The purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Dynamic pelvic MRI with intravaginal probe with pressure sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2021to 13 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All:
- Understanding of the French language
- Signature of informed consent
- Insured social patient
- For pregnant women:
- Primiparous women
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- with no severe maternal-fetal pathology
- with no scheduled caesarean section at the time of the MRI
- For women with prolapse:
- Requires pelvic MRI
Who cannot join
- Minor
- Person who does not have social security
- Person with ongoing vaginal infection
- Pregnant woman during the first or third trimester of pregnancy
- Pregnant woman with broken water pocket
- Bi-cicatricial uterus
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- IVF
- Person wearing a pace maker or any intra-body metal implant (if "tube" MRI)
- Claustrophobic person (if "tube" MRI)
Trial locations and contacts
1 site in 1 country.
About this study
The conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). The purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments (surgery, injection, rehabilitation, etc.). Women requiring pelvic MRI may participate in the study. The pelvic dynamic MRI will be done with an intravaginal probe which will be inserted by the patient herself as well as gel in the anus and vagina which will allow to obtain the data on the characteristics of the pelvic tissues of each woman with a 3D reconstruction.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Dynamic pelvic MRI with intravaginal probe with pressure sensor
- Keywords
- Geometrical reconstruction, Pelvic Floor Disorders, FE models, Pelvic system, MRI
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic pelvic MRI with intravaginal probe with pressure sensorDevice
Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel
| Study group | Role | What they receive |
|---|---|---|
| Dynamic pelvic MRI | Experimental | Not described Receives: Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D reconstruction of the pelvic cavity
Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe.
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start13 Apr 2021
- Primary completion13 May 2021
- Study completion13 May 2021
Why it stopped: inclusion difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel COSSON, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319653
- Sponsor's protocol ID
- 2018_28
- Other IDs
- 2019-A00560-57
- Acronym
- MI-IRM
- Status last verified
- Dec 2025
- First submitted
- 20 Mar 2020
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
- ClinicalTrials.gov ID
- NCT04319653
- Acronym / sponsor ID
- MI-IRM / 2018_28
- Conditions
- Pelvic Floor Disorders
- Keywords
- Geometrical reconstruction, Pelvic Floor Disorders, FE models, Pelvic system, MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulty
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 24 Mar 2020 (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.
The conditions such as childbirth or endometriosis can lead to a change in the mobility of the pelvic organs (bladder, vagina, rectum and uterus). The purpose of the study is to study in a personalized way each woman the characteristics of the tissues of their pelvis and to be able to personalize the treatments (surgery, injection, rehabilitation, etc.). Women requiring pelvic MRI may participate in the study. The pelvic dynamic MRI will be done with an intravaginal probe which will be inserted by the patient herself as well as gel in the anus and vagina which will allow to obtain the data on the characteristics of the pelvic tissues of each woman with a 3D reconstruction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic pelvic MRI | Experimental | Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understanding of the French language
- Signature of informed consent
- Insured social patient
- Primiparous women
- with no severe maternal-fetal pathology
Key exclusion criteria (9 listed)
- Minor
- Person who does not have social security
- Person with ongoing vaginal infection
- Pregnant woman during the first or third trimester of pregnancy
- Pregnant woman with broken water pocket
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 |
|---|---|---|
| Dynamic pelvic MRI with intravaginal probe with pressure sensorDynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel | Device | Dynamic pelvic MRI |
Primary outcome
3D reconstruction of the pelvic cavity
Time frame: at 1 month
Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe.
Results and safety
The study was stopped early (reason given: inclusion difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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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.
Michel COSSON, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic pelvic MRI with intravaginal probe with pressure sensor in people with Pelvic Floor Disorders, run by University Hospital, Lille 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 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 was stopped early (reason given: inclusion difficulty). Results are not available in the source record.
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?
3D reconstruction of the pelvic cavity (time frame: at 1 month). 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 11 Dec 2025.