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

Centre Hospitalier Universitaire de Besancon41 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Sacrospinofixation Apical Prolapse

Interventions

Dynamic Pelvic Floor MRIOTHER

6 months after surgery, a Dynamic Pelvic Floor MRI is performed

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 6 months after surgery

Secondary Outcomes

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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 6 months after surgery

Central Contacts

Marine Lallemant, Dr

CONTACT

+33 3 81 21 94 38 mlallemant@chu-besancon.fr

Michel Cosson, Pr

CONTACT

michel.cosson@chru-lille.fr

Data from ClinicalTrials.gov

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