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

Apical Prolapse Clinical Trial

— BiomécaRichter  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04551859
• Other study ID #: 2020/510
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: November 2021

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Marine Lallemant, Dr
• Phone: +33 3 81 21 94 38
• Email: mlallemant[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 41
• Est. completion date: November 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Prolapse
• Prolapse
• Sacrospinofixation

Intervention

Other:
• Dynamic Pelvic Floor MRI
6 months after surgery, a Dynamic Pelvic Floor MRI is performed

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	University Hospital, Lille

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. French. — View Citation

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. — View Citation

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. Epub 2016 Jul 11. — View Citation

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:CD012376. Review. — View Citation

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. — View Citation

Outcome

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