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

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04319653
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.6
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders	Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Development of a Pelvic Cavity Characterization Algorithm Through the Acquisition of MRI Images and Pressure Measurement by an Intravaginal Probe
• Actual Study Start Date: Apr 13, 2021
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Jeanne de Flandres, CHU	Lille		France

Sponsors and Collaborators

• University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT04319653
• Other Study ID Numbers: 2018_28; 2019-A00560-57
• First Posted: Mar 24, 2020
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Lille: Geometrical reconstruction; Pelvic Floor Disorders; FE models; Pelvic system; MRI
• Additional relevant MeSH terms: Pelvic Floor Disorders

Study Results

No Results Posted as of Mar 2, 2022