Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT03098992
Status:
UNKNOWN
Last Update Posted:
2019-06-12
First Post:
2017-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal']}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-11', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Reduction in 1-hour pad weight between active and sham groups', 'timeFrame': '6 months post-treatment', 'description': 'Reduction in 1-hour pad weight at 6 months post-treatment in active group vs the sham treated group at 6 months post treatment'}, {'measure': 'Safety: Incidence and severity of device related Adverse Events', 'timeFrame': '6 months post-treatment', 'description': 'Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, increased vaginal discharge, de novo urge incontinence).'}], 'secondaryOutcomes': [{'measure': 'Durability of the effect', 'timeFrame': '12 months post-treatment', 'description': 'Reduction in 1hr pad test weight in the treated group at 12 month follow-up vs. pad weight in the same group at baseline'}, {'measure': 'Improvement', 'timeFrame': '6 and 12 months post-treatment', 'description': 'Change in mean Cough Stress test score at 6 and 12 months post-treatment'}, {'measure': "Change in King's Health Questionnaire (KHQ)", 'timeFrame': 'from baseline to 6 and 12 months post-treatment.', 'description': 'Change in mean KHQ from baseline to 6 and 12 months post-treatment'}, {'measure': 'Change in mean PISQ-12 test scores', 'timeFrame': 'from baseline to 6 and 12 months post-treatment.', 'description': 'Change in mean PISQ-12 test scores from baseline to 6 and 12 months post-treatment.'}, {'measure': 'Subjective assessment of pain', 'timeFrame': '6 months', 'description': 'Patient reported assessment of pain during treatment'}, {'measure': 'Change in International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score', 'timeFrame': 'from baseline to 6 and 12 months post-treatment.', 'description': 'Change in mean ICIQ-SF from baseline to 6 and 12 months post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '40709601', 'type': 'DERIVED', 'citation': 'Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.'}]}, 'descriptionModule': {'briefSummary': 'There are many existing treatments of female stress urinary incontinence such as the use of adult absorbent pads and diapers, behavioral training, including bladder training, pelvic muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical stimulation, periurethral injections, and reconstructive surgery. However, there is still a lack of effective minimally invasive treatment options that are independent of patient compliance.\n\nOne emerging approach of minimally invasive SUI therapy is pelvic floor reinforcement using laser therapy.\n\nThe primary objective of this post-marketing study is to confirm the effectiveness and safety of the FotonaSmooth® device in the treatment of stress urinary incontinence (SUI) in a large number of females using objective and subjective methods.\n\nPatients with stress incontinence will be assigned to two groups, an active group, where the Fotona Dynamis Er:YAG Laser System will be used, and a sham group where a very low laser setting will be used, and parameter presentations will be masked.\n\nParticipants will be adult females, 18 years old and older with clinical and urodynamic diagnosis of Stress Urinary Incontinence,who have had no significant improvement in urinary incontinence from at least one previous conservative treatment, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads', 'detailedDescription': 'Prospective, randomized, 2-treatment, sham-controlled, single (patient only) blinded, study design using convenience sampling to enroll subjects as they present and are found to be eligible per the inclusion/exclusion criteria. This multicenter clinical trial utilizes a randomized assignment allocation schedule stratified by clinical site. Allocation rule pertains to the ratio of subjects in each treatment arm. Sampling rules pertain to the number of subjects in each active treatment arm.\n\nTwo treatment arms enrolled on a 2:1 ratio: Active arm is the Fotona Dynamis Er:YAG Laser System and the control arm is a sham treatment with a very low laser setting and parameter presentations masked. The active arm subjects will be followed out to 12 months post-treatment. The sham arm subjects will be followed out to 6 months and then offered the active treatment.'}, '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 UDS diagnosis of Stress Urinary Incontinence,\n* No significant improvement in urinary incontinence from at least one previous conservative treatments, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads\n\nExclusion Criteria:\n\n1. Pre-existing bladder pathology including prior radiation treatment\n2. Pregnancy\n3. BMI\\>35\n4. Radical pelvic surgery or previous incontinence surgery\n5. Urinary tract infection or other active infections of urinary tract or bladder\n6. Endometriosis\n7. Any form of pelvic organ prolapse greater than stage 2, according to POP-Q\n8. Diagnosis of urge incontinence\n9. Diagnosis of collagen disorders e.g. benign joint hypermobility / Elhers-Danlos / Marfans etc.\n10. Incomplete bladder emptying\n11. Vesicovaginal fistula\n12. Fecal incontinence\n13. Unwillingness or inability to complete follow-up schedule\n14. Unwillingness or inability to give Informed Consent\n15. Failure to comply with diary requirements during extended baseline period'}, 'identificationModule': {'nctId': 'NCT03098992', 'briefTitle': 'The Efficacy and Safety of Fotona Smooth® Device for the Treatment of Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Cork University Hospital'}, 'officialTitle': 'Post-market, Prospective, Randomised, Sham-controlled Clinical Trial Designed to Confirm the Efficacy and Safety of the Fotona Smooth® Device to Treat Female Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'FOTONA-Incontilase'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fotona Dynamis Er:YAG Laser System', 'description': 'Active treatment with Fotona Dynamis Er:YAG Laser System', 'interventionNames': ['Device: Fotona Dynamis Er:YAG Laser System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Fotona Dynamis Er:YAG Laser System with Sham handpience', 'description': 'Sham treatment with a sham handpiece and parameter presentations masked', 'interventionNames': ['Device: Fotona Dynamis Er:YAG Laser System with sham handpience']}], 'interventions': [{'name': 'Fotona Dynamis Er:YAG Laser System', 'type': 'DEVICE', 'description': 'Treatment of urodynamic proven stress urinary incontinence using the Fotona Dynamis Er:YAG Laser System in the active arm', 'armGroupLabels': ['Fotona Dynamis Er:YAG Laser System']}, {'name': 'Fotona Dynamis Er:YAG Laser System with sham handpience', 'type': 'DEVICE', 'description': 'Sham treatment with a sham handpiece and parameter presentations masked', 'armGroupLabels': ['Fotona Dynamis Er:YAG Laser System with Sham handpience']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hagen', 'country': 'Germany', 'facility': 'Lutheran Hospital Hagen-Haspe', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'University of Athens, Alexandra Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'Cork Womens Clinic', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Clinical Centre', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern, University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Frauenfeld', 'country': 'Switzerland', 'facility': 'Cantonal Hospital Frauenfeld', 'geoPoint': {'lat': 47.55776, 'lon': 8.89893}}, {'city': 'Basingstoke', 'country': 'United Kingdom', 'facility': 'Basingstoke and North Hampshire Hospital', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Women's Hospital NHS foundation trust", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': "Barry O'Reilly, Professor", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Cork'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cork University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fotona d.o.o.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': "Barry O'Reilly", 'investigatorAffiliation': 'Cork University Hospital'}}}}