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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)

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ClinicalTrials.gov Identifier: NCT04551859
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Sacrospinofixation Apical Prolapse Other: Dynamic Pelvic Floor MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
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
Other: Dynamic Pelvic Floor MRI
6 months after surgery, a Dynamic Pelvic Floor MRI is performed




Primary Outcome Measures :
  1. Concordance of mobility measurements of points C, Ba and Bp between the FE model and the dynamic MRI after SSF [ Time Frame: 6 months after surgery ]
    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 :
  1. Concordance of mobility measurements of points Aa and Ap between the FE model and the dynamic MRI after SSF [ Time Frame: 6 months after surgery ]
    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)

  2. Comparison of the pelvic organ mobility before and after surgery [ Time Frame: 6 months after surgery ]
    Comparison of the mobility of the different points of the POP-Q classification (C, Ba, Bp, Aa, Ap) before and after surgery

  3. Elasticity study of the vaginal tissue (Lille) [ Time Frame: after surgery (day 0) ]
    Elasticity study of the vaginal tissue removed during surgery (for patients operated in Lille only)

  4. Concordance of mobility measurements between FE model enhanced by the vaginal tissue analysis and the dynamic MRI after SSF [ Time Frame: 6 months after surgery ]
    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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551859


Contacts
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Contact: Marine Lallemant, Dr +33 3 81 21 94 38 mlallemant@chu-besancon.fr
Contact: Michel Cosson, Pr michel.cosson@chru-lille.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
University Hospital, Lille
Publications:

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04551859    
Other Study ID Numbers: 2020/510
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Sacrospinofixation
Prolapse
Richter
Vaginal vault
Sacrospinous ligament fixation
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical