Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04319653

Acronym

MI-IRM

Enrollment

Registered

2020-03-24

Start date

2021-04-13

Completion date

2021-05-13

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders

Keywords

Geometrical reconstruction, Pelvic Floor Disorders, FE models, Pelvic system, MRI

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.

Interventions

DEVICEDynamic pelvic MRI with intravaginal probe with pressure sensor

Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
3D reconstruction of the pelvic cavity	at 1 month	Characterization of the pelvic cavity through a double assessment: a pelvic MRI sequence and an intravaginal pressure probe.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026