Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery
NCT ID: NCT04551859
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
41 participants
INTERVENTIONAL
2020-10-31
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Sacrospinofixation
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
Dynamic Pelvic Floor MRI
6 months after surgery, a Dynamic Pelvic Floor MRI is performed
Interventions
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Dynamic Pelvic Floor MRI
6 months after surgery, a Dynamic Pelvic Floor MRI is performed
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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University Hospital, Lille
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Central Contacts
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References
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Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
de Tayrac R, Letouzey V, Costa P, Haab F, Delmas V. [Treatment of uterine prolapse and vaginal vault by vaginal route]. Prog Urol. 2009 Dec;19(13):1074-9. doi: 10.1016/j.purol.2009.09.025. Epub 2009 Oct 21. French.
Cosson M, Rubod C, Vallet A, Witz JF, Dubois P, Brieu M. Simulation of normal pelvic mobilities in building an MRI-validated biomechanical model. Int Urogynecol J. 2013 Jan;24(1):105-12. doi: 10.1007/s00192-012-1842-8. Epub 2012 Jun 16.
Lamblin G, Mayeur O, Giraudet G, Jean Dit Gautier E, Chene G, Brieu M, Rubod C, Cosson M. Pathophysiological aspects of cystocele with a 3D finite elements model. Arch Gynecol Obstet. 2016 Nov;294(5):983-989. doi: 10.1007/s00404-016-4150-6. Epub 2016 Jul 11.
Jeanditgautier E, Mayeur O, Brieu M, Lamblin G, Rubod C, Cosson M. Mobility and stress analysis of different surgical simulations during a sacral colpopexy, using a finite element model of the pelvic system. Int Urogynecol J. 2016 Jun;27(6):951-7. doi: 10.1007/s00192-015-2917-0. Epub 2016 Jan 11.
Cosson M, Rubod C, Vallet A, Witz JF, Brieu M. [Biomechanical modeling of pelvic organ mobility: towards personalized medicine]. Bull Acad Natl Med. 2011 Nov;195(8):1869-83; discussion 1883. French.
Estrade JP, Agostini A, Roger V, Dallay D, Blanc B, Cravello L. [Posthysterectomy prolapse: results of sacrospinous ligament fixation]. J Gynecol Obstet Biol Reprod (Paris). 2005 Sep;34(5):481-7. doi: 10.1016/s0368-2315(05)82856-x. French.
Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD012376. doi: 10.1002/14651858.CD012376.
Lallemant M, Shimojyo AA, Mayeur O, Ramanah R, Rubod C, Kerbage Y, Cosson M. Mobility analysis of a posterior sacrospinous fixation using a finite element model of the pelvic system. PLoS One. 2024 Mar 21;19(3):e0299012. doi: 10.1371/journal.pone.0299012. eCollection 2024.
Other Identifiers
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2020/510
Identifier Type: -
Identifier Source: org_study_id
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