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

Primary Purpose

Sacrospinofixation, Apical Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic Pelvic Floor MRI
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sacrospinofixation focused on measuring Sacrospinofixation, Prolapse, Richter, Vaginal vault, Sacrospinous ligament fixation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Sacrospinofixation

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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)
    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
    Elasticity study of the vaginal tissue (Lille)
    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
    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)

    Full Information

    First Posted
    September 7, 2020
    Last Updated
    September 15, 2020
    Sponsor
    Centre Hospitalier Universitaire de Besancon
    Collaborators
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04551859
    Brief Title
    Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon
    Collaborators
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sacrospinofixation, Apical Prolapse
    Keywords
    Sacrospinofixation, Prolapse, Richter, Vaginal vault, Sacrospinous ligament fixation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    41 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sacrospinofixation
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Dynamic Pelvic Floor MRI
    Intervention Description
    6 months after surgery, a Dynamic Pelvic Floor MRI is performed
    Primary Outcome Measure Information:
    Title
    Concordance of mobility measurements of points C, Ba and Bp between the FE model and the dynamic MRI after SSF
    Description
    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)
    Time Frame
    6 months after surgery
    Secondary Outcome Measure Information:
    Title
    Concordance of mobility measurements of points Aa and Ap between the FE model and the dynamic MRI after SSF
    Description
    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)
    Time Frame
    6 months after surgery
    Title
    Comparison of the pelvic organ mobility before and after surgery
    Description
    Comparison of the mobility of the different points of the POP-Q classification (C, Ba, Bp, Aa, Ap) before and after surgery
    Time Frame
    6 months after surgery
    Title
    Elasticity study of the vaginal tissue (Lille)
    Description
    Elasticity study of the vaginal tissue removed during surgery (for patients operated in Lille only)
    Time Frame
    after surgery (day 0)
    Title
    Concordance of mobility measurements between FE model enhanced by the vaginal tissue analysis and the dynamic MRI after SSF
    Description
    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)
    Time Frame
    6 months after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marine Lallemant, Dr
    Phone
    +33 3 81 21 94 38
    Email
    mlallemant@chu-besancon.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michel Cosson, Pr
    Email
    michel.cosson@chru-lille.fr

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9083302
    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. doi: 10.1016/S0029-7844(97)00058-6.
    Results Reference
    background
    PubMed Identifier
    19969278
    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.
    Results Reference
    background
    PubMed Identifier
    22707008
    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.
    Results Reference
    background
    PubMed Identifier
    27402504
    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. doi: 10.1007/s00404-016-4150-6. Epub 2016 Jul 11.
    Results Reference
    background
    PubMed Identifier
    26755057
    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.
    Results Reference
    background
    PubMed Identifier
    22844748
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16142139
    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. doi: 10.1016/s0368-2315(05)82856-x. French.
    Results Reference
    background
    PubMed Identifier
    27696355
    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(10):CD012376. doi: 10.1002/14651858.CD012376.
    Results Reference
    background

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