Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-26 @ 9:21 PM
Study NCT ID:
NCT02935803
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2016-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-07-12', 'releaseDate': '2019-04-20'}], 'estimatedResultsFirstSubmitDate': '2019-04-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014596', 'term': 'Uterine Prolapse'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the mTVM on genuine stress incontinence.', 'timeFrame': '36 months flollow up', 'description': 'Measuring the anti incontinence effect of the used method by urodynamic examination anf pelvic floor sonography'}], 'secondaryOutcomes': [{'measure': 'Telorability of the mTVM method', 'timeFrame': '36 month follow up', 'description': 'Measuring the tolerability of the used method by the Clavien-Dindo classification system'}, {'measure': 'Improvement in sexual life', 'timeFrame': '36 month', 'description': 'Define the change in quality of sexual life after the used procedures by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)'}, {'measure': 'Improvement in pelvic floor symphtoms', 'timeFrame': '3 years follow up', 'description': 'Define the change in quality of life after the used procedures by Pelvic Floor Distress Inventory (PFDI-20)'}, {'measure': 'Improvement in quality of life', 'timeFrame': '3 years', 'description': 'Define the change in quality of life after the used procedures by urogenital distress inventory (UDI-6)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Uterine Prolapse', 'Urinary Stress Incontinence', 'Side Effects']}, 'referencesModule': {'references': [{'pmid': '18238969', 'type': 'BACKGROUND', 'citation': 'Minassian VA, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31. doi: 10.1097/01.AOG.0000267220.48987.17.'}, {'pmid': '24171152', 'type': 'BACKGROUND', 'citation': 'Kirss F, Lang K, Toompere K, Veerus P. Prevalence and risk factors of urinary incontinence among Estonian postmenopausal women. Springerplus. 2013 Oct 17;2:524. doi: 10.1186/2193-1801-2-524. eCollection 2013.'}, {'pmid': '26638154', 'type': 'BACKGROUND', 'citation': 'Akkus Y, Pinar G. Evaluation of the prevalence, type, severity, and risk factors of urinary incontinence and its impact on quality of life among women in Turkey. Int Urogynecol J. 2016 Jun;27(6):887-93. doi: 10.1007/s00192-015-2904-5. Epub 2015 Dec 5.'}, {'pmid': '19629013', 'type': 'BACKGROUND', 'citation': 'Tinelli A, Malvasi A, Rahimi S, Negro R, Vergara D, Martignago R, Pellegrino M, Cavallotti C. Age-related pelvic floor modifications and prolapse risk factors in postmenopausal women. Menopause. 2010 Jan-Feb;17(1):204-12. doi: 10.1097/gme.0b013e3181b0c2ae.'}, {'pmid': '2333037', 'type': 'BACKGROUND', 'citation': 'Molander U, Milsom I, Ekelund P, Mellstrom D. An epidemiological study of urinary incontinence and related urogenital symptoms in elderly women. Maturitas. 1990 Apr;12(1):51-60. doi: 10.1016/0378-5122(90)90060-j.'}, {'pmid': '26156205', 'type': 'BACKGROUND', 'citation': 'Lau HH, Huang WC, Cheng YW, Wang H, Su TH. Changes in urodynamic measurements and bladder neck position after single-incision trans-vaginal mesh for pelvic organ prolapse. Int Urogynecol J. 2015 Nov;26(11):1629-35. doi: 10.1007/s00192-015-2753-2. Epub 2015 Jul 10.'}, {'pmid': '19643459', 'type': 'BACKGROUND', 'citation': 'Sergent F, Gay-Crosier G, Bisson V, Resch B, Verspyck E, Marpeau L. Ineffectiveness of associating a suburethral tape to a transobturator mesh for cystocele correction on concomitant stress urinary incontinence. Urology. 2009 Oct;74(4):765-70. doi: 10.1016/j.urology.2009.05.038. Epub 2009 Jul 30.'}, {'pmid': '29282115', 'type': 'DERIVED', 'citation': 'Fekete Z, Suranyi A, Renes L, Nemeth G, Kozinszky Z. Efficacy of anchoring the four-arm transvaginal mesh to the mid-urethra vs original surgery as a surgical correction for stress urine incontinence in coexisting anterior vaginal prolapse grades II and III: study protocol for a randomized controlled trial. Trials. 2017 Dec 28;18(1):624. doi: 10.1186/s13063-017-2314-8.'}], 'seeAlsoLinks': [{'url': 'http://www.aspide.com/en/gynecological-urological-surgery/p/surgimesh-prolapse', 'label': 'Surge-Mesh Prolapse by Aspide is used for both TVM method'}]}, 'descriptionModule': {'briefSummary': 'An increasing number of specific procedures have been described for the surgical repair of pelvic organ prolapse (POP) and concomitant stress urinary incontinence (SUI). The investigators introduced an alternative operative method for POP-Q II-III repair and anti-incontinence with the trans vaginal mesh (TVM) anterior edge fixed to the periurethral tissues at the level of mid-urethra. The efficacy and short- and long-term complication profile, of this new surgical technique as compared with those of non-modified TVM.', 'detailedDescription': 'The prospective randomized double blind study comprised 152 women who presented for the correction of stress urinary incontinence (SUI) in conjunction with anterior compartment pelvic organ prolapse stage II-III (POP-Q II-III) at the Departments of Obstetrics and Gynecology at the University of Szeged, Hungary, between June of 2016 and June 2017. After a block randomization method, the patients will divide into two arms, the study group which consist of 76 patients will undergo modified trans vaginal mesh operation (TVM), the rest 76 patients as a control group will undergo a traditional TVM operation. Inclusion criteria in the study is coexisting SUI and POP Q St II-III and signature of the informed consent. The exclusion criteria are as follows: urge, mixed or neurogenic incontinence, occult SUI, previous mesh operations, anti-depressive medical therapy, cancer of the pelvic organs, urinary infections, any sign of voiding difficulties. The transobturator TVM operation (Sergent et al.) has been modofied by inserting a stabilizing suture, which fixing the anterior edge of the mesh to the para-urethral tissues at the level of the mid-urethra with two non-resolvable anchoring stitches thereby promoting the proper elevation and closure of the urethra. The hypothesis is the stabilizing suture treat the coexisting SUI as well. In all cases, urodynamic examinations were carried out before the surgery and urodynamic examinations comprising uroflowmetry, cystography and Valsalva leak point pressure tests and pelvic floor ultrasonography will be performed to determine the coexisting SUI. The efficacy of the POP repair is taken as a significant (\\>1 cm) improvement at points Aa, Ba, C and D according to the POP-Q system (International Continence Society) during the follow-up. The anti-incontinence efficacy is classified as no further SUI diagnosed by urodynamic examination and pelvic floor sonography. All patients will fill two validated Hungarian language questionnaires as "A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire" (PISQ-12) and "Pelvic Floor Distress Inventory" PFDI. After a one-year application phase all patients will be followed for 36 months. During follow- up phase repeated urodynamic studies, pelvic floor sonography urine culturing will be done after 3, 12, 24 and 36 months. The evaluation of the POP-Q system and Bonney\'s cough test and the PISQ-12 and PFDI questionnaires will be performed at every regular check-ups'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coexisting SUI and POP Q St II-III and signature of the informed consent\n\nExclusion Criteria:\n\n* Urge, mixed or neurogenic incontinency, occult SUI, previous mesh operations, antidepressive medical therapy, cancer of the pelvic organs, urinary infections, any sign of voiding difficulties'}, 'identificationModule': {'nctId': 'NCT02935803', 'acronym': 'TVMvsmTVM', 'briefTitle': 'A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'A Prospective and Randomised Single Centre Study on the Anti-incontinent Effectiveness of the Modified Trans Vaginal Mesh Method in POPQ Stage II-III Patients', 'orgStudyIdInfo': {'id': 'TVM/mTVM 55/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Modified TVM operation', 'description': 'Modified Trans-vaginal Mesh operation (mTVM): polypropylene monofilament meshes produced by Aspide® fixed up to the mid urethra by a resolvable suture. 76 participants will be involved.', 'interventionNames': ['Procedure: Trans-vaginal Mesh operation']}, {'type': 'OTHER', 'label': 'Control group', 'description': '76 Participants as control group undergo a traditional Trans-vaginal Mesh operation (TVM) with polypropylene monofilament meshes produced by Aspide® . (Sergent et al.)', 'interventionNames': ['Procedure: Trans-vaginal Mesh operation']}], 'interventions': [{'name': 'Trans-vaginal Mesh operation', 'type': 'PROCEDURE', 'description': 'Modified the transobturator TVM operation reported by Sergent et al. by inserting a stabilizing suture, which fixing the anterior edge of the mesh to the paraurethral tissues at the level of the mid-urethra with two non-resolvable anchoring stitches thereby promoting the proper elevation and closure of the urethra', 'armGroupLabels': ['Control group', 'Modified TVM operation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6720', 'city': 'Szeged', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Fekete Zoltan, M.D.', 'role': 'CONTACT', 'email': 'zoltan.fekete@med.u-szeged.hu', 'phone': '209724158'}], 'facility': 'Univ. of Szeged. Dep. of Obstetrics and Gynaecology', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}], 'centralContacts': [{'name': 'Zoltán Fekete, M.D.', 'role': 'CONTACT', 'email': 'zoltan.fekete@freemail.hu', 'phone': '36209724158'}, {'name': 'Gábor Németh, M.D., PhD', 'role': 'CONTACT', 'email': 'nemethgdr@gmail.com', 'phone': '3662545499'}], 'overallOfficials': [{'name': 'Zoltan Fekete, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Szeged University'}, {'name': 'Gábor Németh, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Szeged University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szeged University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Zoltan Fekete', 'investigatorAffiliation': 'Szeged University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-04-20', 'type': 'RELEASE'}, {'date': '2019-07-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zoltan Fekete, assistant lecturer, Szeged University'}}}}