Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI (DYNPELVIS)

Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.

The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.

This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.

The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.

The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.

Study Overview

• Status: Completed
• Conditions: Pelvic Deformity
• Intervention / Treatment: Diagnostic test: dynamic MRI

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France
    • Marseille, France, France, 13005
      • Assistance Publique Hopitaux de Marseille _ Hopital de la Timone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult women, +/- of childbearing age, with or without effective contraception.
• Informed consent signed prior to any procedure described in the study.

Exclusion Criteria:

• Contraindication to MRI,
• Impossibility of performing the examination during thrust,
• Minor patients
• Pregnant or breast-feeding women,
• Women of legal age under guardianship
• Persons staying in a health or social institution,
• People in emergency situations,
• Persons not covered by a social security scheme,
• Persons deprived of their liberty.
• Specifically, women with IUDs will be excluded if they cannot remove them before the examination.
• For healthy volunteers: history of colorectal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient; Patients requiring dynamic MRI for the diagnosis of pelvic static disorders	Diagnostic test: dynamic MRI; MRI sequences will be performed for patients and healthy volunteers i; Vaginal and rectal tagging will be performed using a water-based ultrasound gel.; The gel will be inserted by an authorized person (nurse or doctor) using a syringe with a conical tip and, optionally, a probe.; MRI sequences.; Data analysis and interpretation.
Active Comparator: control; Healthy volunteers for a dynamic MRI	Diagnostic test: dynamic MRI; MRI sequences will be performed for patients and healthy volunteers i; Vaginal and rectal tagging will be performed using a water-based ultrasound gel.; The gel will be inserted by an authorized person (nurse or doctor) using a syringe with a conical tip and, optionally, a probe.; MRI sequences.; Data analysis and interpretation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.	a metric for displacement of the anchor points of the targeted pelvic organs will be evaluated	0 month

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: RCAPHM20_0016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No