Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT04348994
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2020-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of ICIQ-UI SF scores', 'timeFrame': 'Baseline, 3, 6, 12, 18, 24, 30 and 36 months', 'description': 'Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life.'}, {'measure': 'Assessment of 1 hour pad weight test', 'timeFrame': 'Baseline, 3, 6, 12, 18, 24, 30 and 36 months', 'description': 'The change in standardised 1 hour pad weight test from baseline to 36 months following treatment schedule.'}], 'secondaryOutcomes': [{'measure': 'Change in 24 hour pad weight test', 'timeFrame': 'Baseline, 3, 6, 12, 18, 24, 30 and 36 months', 'description': 'The change in standardised 24 hour pad weight test from baseline to 36 months following treatment schedule.'}, {'measure': 'Change in leakage frequency as assessed by 3 day voiding diary', 'timeFrame': 'Baseline, 3, 6, 12, 18, 24, 30 and 36 months', 'description': 'The change in leakage frequency from baseline to 36 months following treatment schedule.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress urinary incontinence', 'non-ablative Er:YAG laser'], 'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '35067817', 'type': 'DERIVED', 'citation': 'Gaspar A, Koron N, Silva J, Brandi H. Vaginal erbium laser for treatment of stress urinary incontinence: optimization of treatment regimen for a sustained long-term effect. Lasers Med Sci. 2022 Jun;37(4):2157-2164. doi: 10.1007/s10103-021-03474-z. Epub 2022 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for mild-to-severe stages of genuine female stress urinary incontinence (SUI).', 'detailedDescription': 'All patients with urodynamically proven SUI, who have failed/declined conservative therapies will be informed about the study.\n\nThey will be invited to attend a screening/baseline visit. At this visit, they will be asked to perform a standardised 1 hour pad test. Their medical history will be checked and they will undergo a clinical and vaginal examination, pregnancy test and dip stick urinalysis. If their 1 hour pad weight is \\>2g and they meet all other inclusion / exclusion criteria, they will be eligible for inclusion. They will receive detailed instructions for performing a 24 hour pad test, and will be asked to keep a 3 day voiding diary. They will be given the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF).\n\nPatients will then undergo 3 outpatient treatment visits. The timing of visits will be approximately 1 month apart. At each of their 3 outpatient appointments, they will be asked about any deleterious effects since their last appointment. Patients will receive 3 treatments in total.\n\nPatients will be invited to attend a follow-up visits 3, 6, 12 and 18 months after the 3rd treatment and asked to complete the 1 hour pad test, 24 hour pad test, 3 day voiding diary and ICIQ-SF questionnaire.\n\nAt the 18-, 24- and 30-month follow up, they will be given an option to receive additional single session of non-ablative Er:YAG laser treatment. At each visit, and during additional visit after 36 months, they will be asked to complete all of the tests (1 hour pad test, 24 h hour pad test, 3 day voiding diary and ICIQ-UI SF).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Female, 18 years of age or older\n* Clinical and urodynamic study (UDS) diagnosis of Stress Urinary Incontinence\n* No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training\n\nExclusion Criteria:\n\n* Pre-existing bladder pathology including prior radiation treatment\n* Pregnancy\n* BMI\\>35\n* Radical pelvic surgery or previous incontinence surgery\n* Urinary tract infection or other active infections of urinary tract or bladder\n* SUI III (VLPP \\> 60 cm H2O)\n* Any form of pelvic organ prolapse (POP) stage 2 or greater, according to POP-Q\n* Diagnosis of urge incontinence\n* Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.\n* Incomplete bladder emptying\n* Vesicovaginal fistula\n* Faecal incontinence\n* Unwillingness or inability to complete follow-up schedule\n* Unwillingness or inability to give Informed Consent\n* Failure to comply with diary requirements during extended baseline period'}, 'identificationModule': {'nctId': 'NCT04348994', 'briefTitle': 'Long-term Effectiveness of Non-ablative Er: YAG Laser for Treatment of Stress Urinary Incontinence (SUI)', 'organization': {'class': 'OTHER', 'fullName': 'Espacio Gaspar Clinic'}, 'officialTitle': '3-year Follow up of Patients With Stress Urinary Incontinence Treated With Minimally Invasive Er: YAG Laser', 'orgStudyIdInfo': {'id': 'SUI/01/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser therapy', 'description': 'Non-ablative thermal-only Er:YAG laser treatment using IncontiLase® protocol.', 'interventionNames': ['Device: Non-ablative thermal-only Er:YAG laser therapy']}], 'interventions': [{'name': 'Non-ablative thermal-only Er:YAG laser therapy', 'type': 'DEVICE', 'otherNames': ['IncontiLase®'], 'description': 'Each patient will receive 3 sessions of Er:YAG laser treatment for SUI (IncontiLase®).\n\nSingle-session treatments will be offered to patients after 18, 24 and 30 months following the initial three sessions.', 'armGroupLabels': ['Laser therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrian Gaspar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fotona d.o.o.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adrian Gaspar', 'investigatorAffiliation': 'Espacio Gaspar Clinic'}}}}