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SacrospinofixationBiomécaRichterNCT04551859

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

A study testing Dynamic Pelvic Floor MRI in people with Sacrospinofixation and Apical Prolapse, run by Centre Hospitalier Universitaire de Besancon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Sacrospinofixation, Apical Prolapse
What is being tested?
Dynamic Pelvic Floor MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
No sites listed yet
Study dates
Oct 2020to Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Marine Lallemant, Dr contact

+33 3 81 21 94 38

mlallemant@chu-besancon.fr

Michel Cosson, Pr contact

michel.cosson@chru-lille.fr

About this study

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

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

Being tested
Dynamic Pelvic Floor MRI
Keywords
Sacrospinofixation, Prolapse, Richter, Vaginal vault, Sacrospinous ligament fixation
Medical subject headings
Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Pelvic Floor MRIOther

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

Study groups in NCT04551859
Study groupRoleWhat they receive
SacrospinofixationOtherAfter 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
Receives: Other: Dynamic Pelvic Floor MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 months after surgery

Secondary outcomes (4)

  1. 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)

    Measured: 6 months after surgery

  2. 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

    Measured: 6 months after surgery

  3. Elasticity study of the vaginal tissue (Lille)

    Elasticity study of the vaginal tissue removed during surgery (for patients operated in Lille only)

    Measured: after surgery (day 0)

  4. 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)

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study startOct 2020 (estimated)
  3. Primary completionOct 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551859
Sponsor's protocol ID
2020/510
Acronym
BiomécaRichter
Status last verified
Aug 2020
First submitted
7 Sep 2020
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 9083302

  • 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.

    PubMed 19969278

  • 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.

    PubMed 22707008

  • 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.

    PubMed 27402504

  • 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.

    PubMed 26755057

  • 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.

    PubMed 22844748

  • 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.

    PubMed 16142139

  • 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.

    PubMed 27696355

  • 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.

    PubMed 38512958

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Pelvic Floor MRI in people with Sacrospinofixation and Apical Prolapse, run by Centre Hospitalier Universitaire de Besancon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marine Lallemant, Dr (+33 3 81 21 94 38, mlallemant@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551859, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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