Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-07 @ 10:24 AM
Study NCT ID:
NCT03186651
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Lable'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by reported events.', 'timeFrame': '3 weeks', 'description': 'Possible device related adverse reactions'}], 'primaryOutcomes': [{'measure': 'Absolute reduction in leakage as measured by pad weight in gram', 'timeFrame': '3 weeks', 'description': 'The primary endpoint will be the absolute reduction in pad weight from the run-in week (week 1) compared with the final week (week 3). The weight of the pad is defined as the mean weight over the entire week of measurement.'}], 'secondaryOutcomes': [{'measure': 'Success rate in % in reducing urinary leakage measured by pad weight', 'timeFrame': '3 weeks', 'description': 'Overall success rate, defined as at least 70% reduction in pad weight measured in gram from run-in to the final week (week 3).'}, {'measure': 'Reduction of urinary leakage episodes measured by subjective observations', 'timeFrame': '3 weeks', 'description': 'Reduction of SUI episodes from the run-in week compared to the final week (week 3) by entry of subjective observations in study diary.'}, {'measure': 'General impact on quality of life parameters', 'timeFrame': '3 weeks', 'description': 'General impact on quality of life parameters using European Quality of Life - 5 dimensions (EQ-5D-5L) comparing week 1 and week 3.'}, {'measure': 'Impact on disease specific qulity of life parameters', 'timeFrame': '3 weeks', 'description': 'Disease specific Impact of Quality of life parameters, measured by the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) comparing week 1 and week.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginal', 'Medical Device', 'Female Stress Urinary Incontinence'], 'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress urinary incontinence (SUI), will be considered as potential study participants. After written informed consent has been acquired, a medical and surgical history, a physical examination (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed, followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or the standard of care (SoC) group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed Informed Consent Form\n2. Over the age of 18 years\n3. Women diagnosed with stress urinary incontinence\n4. Normal voiding without residual urine ≤100mL\n5. Leakage of at least 10 grams per 24 hours (based on pad-weight test)\n6. Provoking test with leakage\n\nExclusion Criteria:\n\n1. History of dominated urgency's symptoms\n2. Any contraindication for the investigational device; such as hypersensitivity to silicon rubber\n3. Unexplained pelvic bleeding or vaginal discharge\n4. Is hysterectomized,has a history of incontinent surgery or surgery for prolapse correction.\n5. The woman is currently using prolapse ring\n6. Women with prolapse reaching the hymus during coughing.\n7. Pregnant or suspicion of pregnancy\n8. Urinary tract or vaginal infection\n9. History of not being able to use tampons\n10. Neurogenic bladder dysfunction\n11. The patient is to start, or change an ongoing, pelvic floor training\n12. If the patient does not have a well adjusted diuretica, or is to start, or change an ongoing, diuretic treatment\n13. The patient is participating in another study on SUI\n14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate\n15. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment"}, 'identificationModule': {'nctId': 'NCT03186651', 'briefTitle': 'An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Invent Medic Sweden AB'}, 'officialTitle': 'An Open Randomized Controlled Multicenter Clinical Investigation With an Intra-vaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care', 'orgStudyIdInfo': {'id': 'TVS1000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trans Vagina Support', 'description': 'Tension Free Vaginal Support (TVS):The subjects in the TVS Group used pads during week 1 (Baseline), fitted, trained and selected device size week 2 and used the selected device size during week 3 (treatment week).', 'interventionNames': ['Device: TVS']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Standard of care (SoC): The subjects in the SoC group continued with conventional treatment i.e. using pads during week 1, 2 and 3. They were offered to use the TVS device for two weeks after completion of week 3.'}], 'interventions': [{'name': 'TVS', 'type': 'DEVICE', 'description': 'Efficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.', 'armGroupLabels': ['Trans Vagina Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50630', 'city': 'Borås', 'country': 'Sweden', 'facility': 'Ladulaas Kliniska Studier', 'geoPoint': {'lat': 57.72101, 'lon': 12.9401}}, {'zip': '14186', 'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Kvinnokliniken Karolinska Sjukhuset', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}, {'zip': '54150', 'city': 'Skövde', 'country': 'Sweden', 'facility': 'PTC-Skaraborg', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '421 44', 'city': 'Västra Frölunda', 'country': 'Sweden', 'facility': 'PTC-Göteborg', 'geoPoint': {'lat': 57.64667, 'lon': 11.92944}}], 'overallOfficials': [{'name': 'Aino Fianu Jonasson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kvinnokliniken Karolinska sjukhuset'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invent Medic Sweden AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}