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

NCT04319653 | Terminated DMC

• 2 other identifiers: 2018_282019-A00560-57
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dynamic pelvic MRI

EXPERIMENTAL

Device: Dynamic pelvic MRI with intravaginal probe with pressure sensor

Interventions

Dynamic pelvic MRI with intravaginal probe with pressure sensor DEVICE

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

Dynamic pelvic MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The recruitment of patients will be done during a consultation within the Obstetric Gynecology Department CHU of Lille to select those requiring a pelvic MRI.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Jeanne de Flandres, CHU

Lille, France

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Michel COSSON, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: April 13, 2021
• Primary Completion: May 13, 2021
• Study Completion: May 13, 2021
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

FR (1)