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

University Hospital, Lille

Status: Terminated

Conditions: Pelvic Floor Disorders

Treatments: Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT04319653

2019-A00560-57 (Other Identifier)

2018_28

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Dynamic pelvic MRI

Experimental group

Treatment:

Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor