Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-13 @ 12:52 PM
Study NCT ID:
NCT03620604
Status:
UNKNOWN
Last Update Posted:
2018-08-09
First Post:
2018-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female Stress Urinary Incontinence (SUI).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital 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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-07-28', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mid term Efficacy/continence', 'timeFrame': 'Assessed at 24 months of follow up', 'description': 'Mid term Efficacy and continence measured with cough test ( Positive or negative)'}], 'secondaryOutcomes': [{'measure': 'Voiding disfunction', 'timeFrame': 'Assessed every visit at 1,6,12,24 months', 'description': 'Difficulty to void assessed by uroflowmetry (mL/s)'}, {'measure': 'De novo urgency', 'timeFrame': 'Assessed at visit 6,12,24 months', 'description': 'measured by International Consultation on Incontinence Questionnaire Sort Form (ICIQ-SF) ( from 0 to 21 being 0 = to continence and 21= the worse outcome of incontinence)'}, {'measure': 'Safety and adverse events', 'timeFrame': 'Assessed every visit at 1,6,12,24 months', 'description': 'Safety was assessed by physical examination to rule out vaginal extrusion (yes/no)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['single incision sling', 'safety', 'efficacy'], 'conditions': ['Urinary Incontinence,Stress']}, 'referencesModule': {'references': [{'pmid': '27794177', 'type': 'BACKGROUND', 'citation': 'Kocjancic E, Erickson T, Tu LM, Gheiler E, Van Drie D. Two-year outcomes for the Altis(R) adjustable single incision sling system for treatment of stress urinary incontinence. Neurourol Urodyn. 2017 Aug;36(6):1582-1587. doi: 10.1002/nau.23156. Epub 2016 Oct 29.'}, {'pmid': '27679164', 'type': 'BACKGROUND', 'citation': 'Van Drie DM. The Impact of Procedure Setting on Two-Year Outcomes for the Altis Single Incision Sling for Women With Stress Urinary Incontinence. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S243-S244. doi: 10.1016/j.jmig.2015.08.853. Epub 2015 Oct 15. No abstract available.'}, {'pmid': '24599178', 'type': 'BACKGROUND', 'citation': 'Dias J, Xambre L, Costa L, Costa P, Ferraz L. Short-term outcomes of Altis single-incision sling procedure for stress urinary incontinence: a prospective single-center study. Int Urogynecol J. 2014 Aug;25(8):1089-95. doi: 10.1007/s00192-014-2355-4. Epub 2014 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, single-arm, non-sponsored, observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Body mass index(BMI) was categorized according to World Health Organization classification. Valsalva leak point pressure was categorized in three groups \\<60 cmH2O, 60-90 cmH2O and \\>90 cmH2O). Participants were evaluated post-operatively at 1, 6, 12 and 24 months with physical examination, ICIQ-SF, visual scale of satisfaction(SVS)(0-10). Adverse events were reported in each visit. Multivariate analysis for risk factors of surgery failure was performed.', 'detailedDescription': 'This is a prospective, single -arm, non-sponsored observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. Two urologists, experts in female incontinence surgery, performed all procedures. Safety and efficacy were evaluated. All participants provided written informed consent prior to enrolment.\n\nThe investigators recruited female patients aged 35 years or more with urodynamically proven stress urinary incontinence and who had failed to 6 months of non-surgical therapies including behavioural changes and drug therapy. Exclusion criteria were pelvic infection, pelvic organ prolapse ≥Stage 2, prior stress urinary incontinence surgery, neurogenic bladder incontinence, previous pelvic radiotherapy, high post-voiding volume (100 mL in two times) or being pregnant.\n\nDemographic variables (age, number of vaginal deliveries, prior stress urinary incontinence surgery, menopause status, BMI and presence of urge incontinence) were collected. BMI was categorized according to World Health Organization in normal (18,5-24,9 Kg/m2), overweight (25-29,9 Kg/m2) and obese (≥ 30 Kg/m2) patients. For statistical purpose the investigators divided patients into two groups, non-obese (18,5-29,9) Kg/m2) and obese (≥ 30 Kg/m2) patients.\n\nPreoperative assessment included urogynecological history, cough test (stress test with at least 300 mL of bladder volume measured by ultrasound), Spanish validated version of the International Consultation on Incontinence Questionnaire sort form (ICIQ-SF) and urodynamic test (Urodynamic parameters as Valsalva leak point pressure (VLPP), non-inhibited detrusor contractions and post-voiding volume were reflected. VLPP was categorized into three groups \\<60 cmH2O, 60-90 cmH2O and \\>90 cmH2O).\n\nFollow up was carried out with physical examination, ICIQ-SF, visual scale of satisfaction and physical examination including cough test. Subjects were evaluated post-operatively at 1, 6, 12 and 24 months. Adverse events, such as vaginal erosion or pain related to the procedure or the device were evaluated at each visit.\n\nThe primary efficacy measures were objective cure, defined as negative cough test, and subjective cure, defined as ICIQ-SF=0.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were selected from our National Health System both forwarded from primary care or f from gynecology or other urologist to de Urodynamic Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Urodynamically proven stress urinary incontinence\n* Refractory to 6 months of non-surgical therapies including behavioural changes or drug therapy\n\nExclusion Criteria:\n\n* Pelvic infection\n* Pelvic organ prolapse ≥Stage 2\n* Prior stress urinary incontinence surgery\n* Neurogenic bladder incontinence,\n* Previous pelvic radiotherapy,\n* High post-voiding volume (100 mL in two times)\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT03620604', 'briefTitle': 'Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female Stress Urinary Incontinence (SUI).', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigacion Sanitaria La Fe'}, 'officialTitle': 'Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female SUI. Less Mesh, Same Results.', 'orgStudyIdInfo': {'id': 'ALTIS STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stress urinary incontinence surgery', 'description': 'This is a single observational study were all patients had stress urinary incontinence. All of them underwent surgery performing a single incision sling type ALTIS', 'interventionNames': ['Device: Stress urinary incontinence surgery']}], 'interventions': [{'name': 'Stress urinary incontinence surgery', 'type': 'DEVICE', 'otherNames': ['ALTIS device'], 'description': 'All patients were treated according to the Urology protocols of our unit. They were patients with stress urinary incontinence refractory to pelvic floor exercises so they underwent surgery', 'armGroupLabels': ['Stress urinary incontinence surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politecnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Eduardo J Moran Pascual, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Fe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "This is a single centre study we don't think it will be useful to make these data available to other researchers"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigacion Sanitaria La Fe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urologist', 'investigatorFullName': 'Eduardo Moran', 'investigatorAffiliation': 'Instituto de Investigacion Sanitaria La Fe'}}}}