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

Not Applicable

• Conditions: Pelvic Floor Disorders
• Interventions: Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor

• Registration Number: NCT04319653
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Study Start: 2021-04-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic pelvic MRI	Dynamic pelvic MRI with intravaginal probe with pressure sensor	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Jeanne de Flandres, CHU; 🇫🇷 Lille, France