Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate the feasibility of using a Finite Element model of pelvic organs by evaluating the concordance of pelvic organ mobility measurements performed by this mechanical model compared to the observations on the post-operative pelvic MRI in patients undergoing a sacrospinofixation surgery

Official Title
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Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinous Ligament Fixation Surgery

Conditions
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Sacrospinofixation, Apical Prolapse

Intervention / Treatment
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* Other: Dynamic Pelvic Floor MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 to 80 With at least a grade II apical prolapse according to the POP-Q classification Treated with a sacrospinous ligament fixation (SSF) by the vaginal route Exclusion Criteria: History of abdominal, pelvic, vaginal or vulvar surgery except hysterectomy Association of another POP or urinary incontinence surgery (subvesical plication, levator myorrhaphy, plication of anterior rectal wall, perineorrhaphy ...) MRI contraindication Legal incapacity or limited legal capacity Subject unlikely to cooperate with the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sacrospinofixation<br>After accepting the surgeon's proposal to perform a sacrospinofixation to treat the pelvic organ prolapse, participation in this study will be proposed to the patient. It will not change the management or the course of the surgery | Other: Dynamic Pelvic Floor MRI<br>* 6 months after surgery, a Dynamic Pelvic Floor MRI is performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of mobility measurements of points C, Ba and Bp between the FE model and the dynamic MRI after SSF | Concordance of mobility measurements of the 3 points C, Ba, Bp during the defecation sequence, between the Finite Elements (FE) model and the dynamic pelvic floor MRI after sacrospinous ligament fixation (SSF) | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of mobility measurements of points Aa and Ap between the FE model and the dynamic MRI after SSF | Concordance of mobility measurements of points Aa and Ap during the defecation sequence, between the Finite Elements (FE) model and the dynamic pelvic floor MRI after sacrospinous ligament fixation SSF) | 6 months after surgery | 
| Comparison of the pelvic organ mobility before and after surgery | Comparison of the mobility of the different points of the POP-Q classification (C, Ba, Bp, Aa, Ap) before and after surgery | 6 months after surgery | 
| Elasticity study of the vaginal tissue (Lille) | Elasticity study of the vaginal tissue removed during surgery (for patients operated in Lille only) | after surgery (day 0) | 
| Concordance of mobility measurements between FE model enhanced by the vaginal tissue analysis and the dynamic MRI after SSF | Concordance of mobility measurements of the POP-Q points (C, Ba, Bp, Aa, Ba) during the defecation sequence, between the Finite Elements (FE) model enhanced by the analysis of the vaginal tissue sampling and the dynamic pelvic floor MRI after sacrospinous ligament fixation (SSF) | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacrospinofixation, Prolapse, Richter, Vaginal vault, Sacrospinous ligament fixation