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

Not Applicable

• Conditions: Sacrospinofixation; Apical Prolapse
• Interventions: Other: Dynamic Pelvic Floor MRI

• Registration Number: NCT04551859
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Study Start: 2020-10
• Primary Completion: 2021-10
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sacrospinofixation	Dynamic Pelvic Floor MRI	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

Primary Outcome Measures

Name	Time	Method
Concordance of mobility measurements of points C, Ba and Bp between the FE model and the dynamic MRI after SSF	6 months after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Concordance of mobility measurements of points Aa and Ap between the FE model and the dynamic MRI after SSF	6 months after surgery	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)
Comparison of the pelvic organ mobility before and after surgery	6 months after surgery	Comparison of the mobility of the different points of the POP-Q classification (C, Ba, Bp, Aa, Ap) before and after surgery
Elasticity study of the vaginal tissue (Lille)	after surgery (day 0)	Elasticity study of the vaginal tissue removed during surgery (for patients operated in Lille only)
Concordance of mobility measurements between FE model enhanced by the vaginal tissue analysis and the dynamic MRI after SSF	6 months after surgery	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)