Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT01348334
Status:
COMPLETED
Last Update Posted:
2011-05-05
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synthetic Mesh Materials In Sling Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-07', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-04', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-05-04', 'lastUpdatePostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'continence rates at three years after surgery', 'timeFrame': 'three years after surgery', 'description': 'Ultrapromesh® with its superior biomechanical characteristics and with its high success rates,low vaginal and urethral extrusion and denovo urgency rates determined in clinical studies,can be reliably and effectively used in sling surgery.'}], 'secondaryOutcomes': [{'measure': 'urethral erosion at three years after surgery', 'timeFrame': 'three years after surgery'}, {'measure': 'vaginal erosion at three years after surgery', 'timeFrame': 'three years after surgery'}, {'measure': 'Denovo urgency at three years after surgery', 'timeFrame': 'three years after surgery'}, {'measure': 'urine retantion at three years after surgery', 'timeFrame': 'three years after surgery'}, {'measure': 'sutur granuloma at three years after surgery', 'timeFrame': 'three years after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sling surgery', 'synthetic meshes', 'ultrapromesh®', 'mix mesh', 'incontinence', 'The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.'], 'conditions': ['Incontinence']}, 'referencesModule': {'references': [{'pmid': '37888839', 'type': 'DERIVED', 'citation': 'Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first time in literature.', 'detailedDescription': 'Broad based double forced sling operations were performed in 144 patients by using 3 different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light mesh® (Johnson\\&Johnson,USA) was used. The data of the patients and the success of the operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire analysis.\n\nMain outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '31 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stress urinary incontinence\n* Mix urinary incontinence\n* Previous failed anti-incontinence surgery\n* Previous gynecologic surgery\n\nExclusion Criteria:\n\n* Urodynamical detrusor overactivity or impaired bladder activity\n* Prolaps of pelvic organ\n* Urge incontinence\n* Neurogenic bladder\n* Bladder outlet obstruction\n* Urinary fistula, Pregnancy\n* Active urinary or vaginal enfection\n* Contraindication to anesthesia\n* \\> 100ml PVR urine volume'}, 'identificationModule': {'nctId': 'NCT01348334', 'briefTitle': 'Synthetic Mesh Materials In Sling Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications', 'orgStudyIdInfo': {'id': 'Ataturk TRH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vypromesh®(Ethicon,USA)', 'description': 'Vypromesh®(semiabsorbable multiflament mesh;non-absorbable Polypropylene+absorbable Poliglactin)', 'interventionNames': ['Procedure: Synthetic sling surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrapromesh®(Ethicon,USA)', 'description': 'Ultrapromesh®(semiabsorbable monofilament mesh;non-absorbable Polypropylene+absorbable polyglecaprone).', 'interventionNames': ['Procedure: Synthetic sling surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolene light mesh®(Johnson&Johnson,USA)', 'description': 'Prolene light mesh®(cpp-Condensed monofilament non absorbable polypropylene mesh)', 'interventionNames': ['Procedure: Synthetic sling surgery']}], 'interventions': [{'name': 'Synthetic sling surgery', 'type': 'PROCEDURE', 'description': 'An incision of inverted A shape was inflicted on the anterior vaginal wall(AVW)of the vagina.The upper part of A shaped incision was formed into an island belonging to the vaginal wall.This patch was 3×4cm in most of the patients.Proximal AVWwas dissected as a flap.Synthetics mesh materials were first sutured onto the upper part of the A on the vaginal island with absorbable vicrly sutures.Then,with 2polypropilen sutures,these meshes were fixed on both the right and left sides of this island in a helical manner to form a suspension and using curved Kishner needles,the prolene sutures were transferred to suprapubic area.These sutures were ligated on the rectus fascia in a crosswise manner.The mobile lower wing was advanced onto the island and was sutured onto the vaginal skin with intermittent sutures using 3-0 monocryl sutures.After cystoscopy,the prolene sutures were ligated crosswise in the suprapubic region.Special attention was paid notto create much tension on the mesh material.', 'armGroupLabels': ['Prolene light mesh®(Johnson&Johnson,USA)', 'Ultrapromesh®(Ethicon,USA)', 'Vypromesh®(Ethicon,USA)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Emrah Okulu', 'oldOrganization': 'Ataturk Training and Research Hospital'}}}}