Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe (MI-IRM)

  • STATUS
    Recruiting
  • End date
    Apr 13, 2024
  • participants needed
    50
  • sponsor
    University Hospital, Lille
Updated on 13 March 2022
prenatal

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 (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.

Details
Condition Pelvic Floor Disorders
Treatment Dynamic pelvic MRI with intravaginal probe with pressure sensor
Clinical Study IdentifierNCT04319653
SponsorUniversity Hospital, Lille
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All
Understanding of the French language
Signature of informed consent
Insured social patient
For pregnant women
Primiparous women
with no severe maternal-fetal pathology
with no scheduled caesarean section at the time of the MRI
For women with prolapse
Requires pelvic MRI

Exclusion Criteria

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
IVF
Person wearing a pace maker or any intra-body metal implant (if "tube" MRI)
Claustrophobic person (if "tube" MRI)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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