NCT04551859|Unknown
Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery
BiomécaRichter
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BiomécaRichter
Sponsor study identifier
interventional
41
0 countries
N/A
Study Start
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2020
Actual (reported)September 16, 2020
Actual (reported)October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
6 months after surgery
Concordance of mobility measurements of points Aa and Ap between the FE model and the dynamic MRI after SSF
6 months after surgery
Comparison of the pelvic organ mobility before and after surgery
6 months after surgery
Elasticity study of the vaginal tissue (Lille)
after surgery (day 0)
Concordance of mobility measurements between FE model enhanced by the vaginal tissue analysis and the dynamic MRI after SSF
6 months after surgery
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
6 months after surgery, a Dynamic Pelvic Floor MRI is performed
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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.
First Submitted
September 7, 2020
First Posted
September 16, 2020
Study Start
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2021
Estimated (date passed)Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 16, 2020
Record last verified: 2020-08
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