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

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 Overview

• Status: Terminated
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Jeanne de Flandres, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic pelvic MRI	Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor; Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Michel COSSON, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): May 13, 2021
• Study Completion (Actual): May 13, 2021

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Pelvic Floor Disorders; Geometrical reconstruction; FE models; Pelvic system
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: 2018_28; 2019-A00560-57 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No