Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- 3D reconstruction of the pelvic cavity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
- •Person wearing a pace maker or any intra-body metal implant (if "tube" MRI)
- •Claustrophobic person (if "tube" MRI)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported