Apical Prolapse, Sacrospinofixation
Conditions
Keywords
Sacrospinofixation, Prolapse, Richter, Vaginal vault, Sacrospinous ligament fixation
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
Interventions
OTHERDynamic Pelvic Floor MRI
6 months after surgery, a Dynamic Pelvic Floor MRI is performed
Sponsors
University Hospital, Lille
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactMarine Lallemant, Dr
Backup ContactMichel Cosson, Pr
Outcome results
None listed