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

NCT04551859 | Unknown

• 1 other identifier: 2020/510
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sacrospinofixation; Apical Prolapse

Keywords

Sacrospinofixation; Prolapse; Richter; Vaginal vault; Sacrospinous ligament fixation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Sacrospinofixation

OTHER

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

Other: Dynamic Pelvic Floor MRI

Interventions

Dynamic Pelvic Floor MRI OTHER

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

Sacrospinofixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• University Hospital, Lille: collaborator

Related Publications (9)

• 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.

  PMID: 9083302 BACKGROUND

• 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.

  PMID: 19969278 BACKGROUND

• 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.

  PMID: 22707008 BACKGROUND

• 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.

  PMID: 27402504 BACKGROUND

• 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.

  PMID: 26755057 BACKGROUND

• 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.

  PMID: 22844748 BACKGROUND

• 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.

  PMID: 16142139 BACKGROUND

• 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.

  PMID: 27696355 BACKGROUND

• 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.

  PMID: 38512958 DERIVED

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marine Lallemant, Dr

CONTACT

+33 3 81 21 94 38; mlallemant@chu-besancon.fr

Michel Cosson, Pr

CONTACT

michel.cosson@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-08