Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis

NCT03881436 | Completed

• 1 other identifier: 18-005
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary and faecal incontinences generally come from a dysfunction of the pelvic floor muscles, and more particularly the sphincters. Among other causes, they may be related to accidental trauma, obstetric or iatrogenic. On this last point, the incidence of surgical interventions on the bladder collar and on the anal canal on the prevalence of incontinences can be underlined. MRI tractography could be an interesting tool to visualize in 3D the structure of pelvic sphincters and their lesions. It may thereby establish the link with observed dysfunctions, thus potentially providing a complement to the urological and proctographic examinations already carried out. The objective of this study is, first, to define the sensitivity of the MRI tractography for the visualization of the pelvic sphincters architecture regardless of the gender. In a second time, it will give a description of normal and abnormal (pathological cases) tractography, as well as a descriptive post-surgery. The other interest of this study is the assessment of the information provided by pelvic sphincters tractography on a panel of various and frequently encountered situations in clinical routine at the IHU.

Conditions

Inflammatory Bowel Disease; Neoplastic Pathology

Keywords

Anatomy; Fiber tractography; Pelvic floor; Diffusion Tensor Imaging (DTI); Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• The ability of MRI tractography to visualize the muscular architecture of pelvic sphincters evaluated with a Likert score.

  This criterion is quantitative and is evaluated on the basis of a Likert score varying between 1 and 5 which will be attributed to each sphincter. * Score 1 = no reconstruction: sphincter not visualised * Score 2 = insufficient reconstruction: the fiber architecture is incoherent and / or few fibers are rebuilt * Score 3 = acceptable reconstruction: the reconstructed fibers provide an overview of sphincter architecture despite the presence of incoherent or missing fibers * Score 4 = satisfactory reconstruction: the sphincter is generally well reconstructed, little incoherence and missing fibers * Score 5 = excellent reconstruction: the appearance of the sphincter reflects the expected anatomy, without missing or inconsistent fibers.

  1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group

Secondary Outcomes (4)

• Evaluation of the sphincter orientation based on a color gradient.

  1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group

• Thickness of the sphincters evaluated in millimetres

  1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group

• Fractional Anisotropy (FA) Values in Sphincter Fibres

  1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group

• Apparent Diffusion Coefficient (ADC) Values in Sphincter Fibres

  1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group

Study Arms (2)

Pelvic MRI

EXPERIMENTAL

This arm involves patients undergoing a pelvic MRI. At the end of the planned sequence, but before any contrast agent injection: * Acquisition of a an additional anatomical T2 SPACE sequence * Acquisition of a tractography Diffusion Tensor Imaging (DTI) sequence All acquisitions will be done in an acceptable duration (less than 45 minutes)

Diagnostic Test: MRI with DTI sequence

Pelvic surgery

EXPERIMENTAL

This arm involves patients undergoing a pelvic surgery and coming for a postoperative MRI. An additional MRI is performed before the surgery and additional sequences are added to the planned postoperative MRI, at the end of the planned sequence, but before any contrast agent injection: * Acquisition of a an additional anatomical T2 SPACE sequence * Acquisition of a tractography Diffusion Tensor Imaging (DTI) sequence All acquisitions will be done in an acceptable duration (less than 45 minutes)

Diagnostic Test: MRI with DTI sequence

Interventions

MRI with DTI sequence DIAGNOSTIC_TEST

At the end of the planned sequence, but before any contrast agent injection: * Acquisition of a an additional anatomical T2 SPACE sequence * Acquisition of a tractography DTI sequence

Pelvic MRI; Pelvic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female over 18 years old
• Patient able to receive and understand information related to the study and give written informed consent
• Patient affiliated to the French social security system
• Patient undergoing a pelvic MRI examination whose result at the end of the T2 sequences in the 3 section planes shows the absence of pathology or a distant pathology that does not affect the pelvic sphincters OR Patient undergoing a pelvic surgery including fistula treatment, abscess treatment, sigmoid mucosectomy or rectal mucosectomy

You may not qualify if:

• Patient who previously had a therapeutic procedure affecting the sphincters
• Patient with hip prostheses
• Patient with contraindications to MRI:
• pacemaker or automatic defibrillator, pump
• implanted
• auditory, anal, painkiller neurostimulator, etc ...
• ferromagnetic bodies in soft tissues, body
• intraocular foreigners, cerebrovascular clips
• claustrophobia
• Patient presenting, in the judgment of the investigator, an illness that may prevent participation in the procedures provided by the study
• Pregnant or lactating patient
• Patient under guardianship or trusteeship
• Patient under the protection of justice

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Radiologie et d'Echographie, NHC Strasbourg

Strasbourg, 67 091, France

Location

Related Publications (3)

• Zijta FM, Froeling M, van der Paardt MP, Lakeman MM, Bipat S, van Swijndregt AD, Strijkers GJ, Nederveen AJ, Stoker J. Feasibility of diffusion tensor imaging (DTI) with fibre tractography of the normal female pelvic floor. Eur Radiol. 2011 Jun;21(6):1243-9. doi: 10.1007/s00330-010-2044-8. Epub 2011 Jan 1.

  PMID: 21197534 BACKGROUND

• Zijta FM, Lakeman MM, Froeling M, van der Paardt MP, Borstlap CS, Bipat S, Montauban van Swijndregt AD, Strijkers GJ, Roovers JP, Nederveen AJ, Stoker J. Evaluation of the female pelvic floor in pelvic organ prolapse using 3.0-Tesla diffusion tensor imaging and fibre tractography. Eur Radiol. 2012 Dec;22(12):2806-13. doi: 10.1007/s00330-012-2548-5. Epub 2012 Jul 14.

  PMID: 22797954 BACKGROUND

• Rousset P, Delmas V, Buy JN, Rahmouni A, Vadrot D, Deux JF. In vivo visualization of the levator ani muscle subdivisions using MR fiber tractography with diffusion tensor imaging. J Anat. 2012 Sep;221(3):221-8. doi: 10.1111/j.1469-7580.2012.01538.x. Epub 2012 Jul 4.

  PMID: 22757638 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Catherine ROY, MD

  Service de Radiologie et d'Echographie, NHC Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 19, 2019
• Study Start: August 12, 2019
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)