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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Sacrospinofixation; Apical Prolapse

Treatments: Other: Dynamic Pelvic Floor MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04551859

2020/510

Details and patient eligibility

About

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

Enrollment: 41 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Sacrospinofixation

Other group

Description:

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

Treatment:

Other: Dynamic Pelvic Floor MRI