Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis (NCT03881436) | Clinical Trial Compass
CompletedNot Applicable
Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis
France23 participantsStarted 2019-08-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Patient who previously had a therapeutic procedure affecting the sphincters
✕. Patient with hip prostheses
✕. Patient with contraindications to MRI:
✕. Patient presenting, in the judgment of the investigator, an illness that may prevent participation in the procedures provided by the study
✕
What they're measuring
1
The ability of MRI tractography to visualize the muscular architecture of pelvic sphincters evaluated with a Likert score.
Timeframe: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group