Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-29 @ 1:38 AM
Study NCT ID:
NCT04551859
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011391', 'term': 'Prolapse'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance of mobility measurements of points C, Ba and Bp between the FE model and the dynamic MRI after SSF', 'timeFrame': '6 months after surgery', '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)'}], 'secondaryOutcomes': [{'measure': 'Concordance of mobility measurements of points Aa and Ap between the FE model and the dynamic MRI after SSF', 'timeFrame': '6 months after surgery', '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)'}, {'measure': 'Comparison of the pelvic organ mobility before and after surgery', 'timeFrame': '6 months 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'}, {'measure': 'Elasticity study of the vaginal tissue (Lille)', 'timeFrame': 'after surgery (day 0)', 'description': 'Elasticity study of the vaginal tissue removed during surgery (for patients operated in Lille only)'}, {'measure': 'Concordance of mobility measurements between FE model enhanced by the vaginal tissue analysis and the dynamic MRI after SSF', 'timeFrame': '6 months after surgery', '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sacrospinofixation', 'Prolapse', 'Richter', 'Vaginal vault', 'Sacrospinous ligament fixation'], 'conditions': ['Sacrospinofixation', 'Apical Prolapse']}, 'referencesModule': {'references': [{'pmid': '9083302', 'type': 'BACKGROUND', '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.'}, {'pmid': '19969278', 'type': 'BACKGROUND', '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.'}, {'pmid': '22707008', 'type': 'BACKGROUND', '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.'}, {'pmid': '27402504', 'type': 'BACKGROUND', '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.'}, {'pmid': '26755057', 'type': 'BACKGROUND', '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.'}, {'pmid': '22844748', 'type': 'BACKGROUND', '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.'}, {'pmid': '16142139', 'type': 'BACKGROUND', '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.'}, {'pmid': '27696355', 'type': 'BACKGROUND', '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.'}, {'pmid': '38512958', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 to 80\n* With at least a grade II apical prolapse according to the POP-Q classification\n* Treated with a sacrospinous ligament fixation (SSF) by the vaginal route\n\nExclusion Criteria:\n\n* History of abdominal, pelvic, vaginal or vulvar surgery except hysterectomy\n* Association of another POP or urinary incontinence surgery (subvesical plication, levator myorrhaphy, plication of anterior rectal wall, perineorrhaphy ...)\n* MRI contraindication\n* Legal incapacity or limited legal capacity\n* Subject unlikely to cooperate with the study'}, 'identificationModule': {'nctId': 'NCT04551859', 'acronym': 'BiomécaRichter', 'briefTitle': 'Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2020/510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sacrospinofixation', '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", 'interventionNames': ['Other: Dynamic Pelvic Floor MRI']}], 'interventions': [{'name': 'Dynamic Pelvic Floor MRI', 'type': 'OTHER', 'description': '6 months after surgery, a Dynamic Pelvic Floor MRI is performed', 'armGroupLabels': ['Sacrospinofixation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marine Lallemant, Dr', 'role': 'CONTACT', 'email': 'mlallemant@chu-besancon.fr', 'phone': '+33 3 81 21 94 38'}, {'name': 'Michel Cosson, Pr', 'role': 'CONTACT', 'email': 'michel.cosson@chru-lille.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Lille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}