Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT03676894
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, 3-arm parallel pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability of the 2940nm Er:YAG laser technique by VAS pain scale', 'timeFrame': '18 months', 'description': 'The tolerability of intra-urethral/intravaginal Er:YAG laser treatment by VAS pain scale during procedure and by monitoring the use of pain relieving medication post treatment. The Visual Analog Scale for Pain (VAS) is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.'}, {'measure': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence and severity of complications', 'timeFrame': '18 months', 'description': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence and severity of complications'}, {'measure': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure by recording the incidence of device related adverse events', 'timeFrame': '18 months', 'description': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by recording the incidence of device related adverse events'}, {'measure': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure by measure uroflow and post void residual (PVR)', 'timeFrame': '18 months', 'description': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by measure uroflow and post void residual (PVR) 6 months after the 2ed treatment'}, {'measure': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure by Questionnaire for voiding symptoms (based on IPSS)', 'timeFrame': '18 months', 'description': 'The Safety of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women, as assessed by questionnaire for voiding symptoms (based on IPSS)'}], 'secondaryOutcomes': [{'measure': 'The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording 3-day voiding diary', 'timeFrame': '18 months', 'description': 'The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording of improvement in daily number of incontinence episodes via 3-day voiding diary The 3-day voiding diary is a log used to record number of pads used, incontinence episodes, the activity in which the subject was engaged when the incontinence occurred, and micturitions.'}, {'measure': 'The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by 24-Hour Pad-Weight Test', 'timeFrame': '18 months', 'description': 'The 24-Hour Pad-Weight Test will be used to reflect everyday incontinence. This test, standardized by the International Continence Society, correlates well with UI symptoms, and has good reproducibility.'}, {'measure': 'The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by ICIQ-UI short form questionnaire', 'timeFrame': '18 months', 'description': 'The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women reduction in SUI as measured by ICIQ-UI short form questionnaire. The ICIQ-UI Short Form Questionnaire provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment.'}, {'measure': 'The effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments by recording patient global impression of improvement (PGI-I)', 'timeFrame': '18 months', 'description': '• The efficacy of intra-urethral/intravaginal Er:YAG laser procedure for the treatment of stress urinary incontinence in women by recording patient global impression of improvement (PGI-I). The Patient Global Impression of Improvement (PGI-I) Questionnaire is a global index that may be used to rate the response of a condition to a therapy (transition scale).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence.', 'detailedDescription': 'This study is a prospective, randomized, 3-arm parallel pilot study. Study subjects will be women currently experiencing female stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI) with a degree of intrinsic sphincter deficiency for a minimum duration of 6 months prior to enrolment. Diagnosis of SUI with a degree of intrinsic sphincter deficiency will be performed using urodynamic and clinical assessment.\n\nSubjects will undergo sham, intravaginal, and the combination of intravaginal and intraurethral treatment with the 2940 nm Er:yttrium aluminum garnet Er:YAG laser at two time points, 4 weeks apart. Primary objective is to assess the tolerability and safety of the intraurethral 2940nm Er:YAG laser technique in combination with intravaginal 2940nm Er:YAG laser method for the treatment of stress urinary incontinence through 6 months follow-up and extend to 12 months follow-up.\n\nSecondary objective is to assess the effectiveness of the intravaginal and combination of intraurethral/intravaginal laser treatments using subjective and objective measures, as well as improvement in quality of life through 6 months follow-up and extend to 12 months follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female between 18 and 80 years\n* SUI or MUI with predominantly stress symptoms for more than 6 months\n* Has failed 2 previous non-invasive therapies for three (3) months each (e.g. behavioural modification, electrical stimulation, pelvic muscle exercise, biofeedback, and/or drug therapy)\n* Confirmed SUI through cough stress test or urodynamics\n* Has at least one incontinence episode per 24 hour period measured over three days\n* Valsalva leak-point pressure (VLPP) ≤100 cm H2O\n* Has a baseline 24h pad weight test ≥ 10 gm\n* Has maximum cystometric capacity ≥250 mL\n* No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)\n* Willing to give informed consent and complete the follow up schedule\n\nExclusion Criteria:\n\n* Active urinary tract or vaginal infection or other active infections of urinary tract or bladder (urethritis, cystitis or vaginitis)\n* Has had three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months\n* Clinical diagnosis of urge incontinence or urge predominant mixed incontinence\n* Has detrusor overactivity on urodynamics\n* postvoiding residual (PVR) \\> 100 ml\n* Has had previous urethral surgery (i.e. fistula or diverticula)\n* Grade 2 or higher Pelvic organ prolapse (POP) or Pelvic organ prolapse grade \\> 2 as defined by POP-Q and symptomatic\n* Suffers from known polyuria (\\>3l/24h)\n* Has a BMI ≤35 kg/m2\n* Has unevaluated hematuria\n* Has a neurogenic bladder\n* Evidence of dysplasia in a Pap smear (done in the last 24 months)\n* Tumours of the Urinary tract\n* Previous radiation or brachytherapy to treat pelvic cancer\n* Has uncontrolled diabetes\n* Has active herpes genitalis\n* Pregnancy, lactating, or not practicing adequate contraception and/or planning to get pregnant in the next 12 months\n* Had a vaginal delivery within 6 months prior to the Screening/Baseline Visit\n* Is currently participating in any other clinical trial, or has participated in another clinical trial within 3 months prior to the Screening/Baseline Visit'}, 'identificationModule': {'nctId': 'NCT03676894', 'briefTitle': 'Intraurethral/Intravaginal 2940 Nm Erbium Laser Treatment for Stress Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fotona d.o.o.'}, 'officialTitle': 'Pilot Single-masked, Randomized, 3-arm Parallel Study Assessing the Tolerability, Safety and Efficacy of Intraurethral/Intravaginal 2940 Nm Er:YAG Laser Treatment for Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'SPD16-001-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Treatment', 'description': 'Sham Fotona SP Dynamis Treatment - minimum energy delivered through sham handpiece.', 'interventionNames': ['Device: Sham Fotona SP Dynamis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravaginal Treatment', 'description': 'Intravaginal Fotona SP Dynamis Treatment - energy delivered intravaginally.', 'interventionNames': ['Device: Intravaginal Fotona SP Dynamis']}, {'type': 'EXPERIMENTAL', 'label': 'Intravaginal and intraurethral Treatment', 'description': 'Intravaginal and intraurethral Fotona SP Dynamis Treatment Intravaginal Treatment - energy delivered intravaginally and intraurethrally.', 'interventionNames': ['Device: Intravaginal Fotona SP Dynamis', 'Device: Intraurethral Fotona SP Dynamis']}], 'interventions': [{'name': 'Sham Fotona SP Dynamis', 'type': 'DEVICE', 'description': 'Female patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece.', 'armGroupLabels': ['Sham Treatment']}, {'name': 'Intravaginal Fotona SP Dynamis', 'type': 'DEVICE', 'description': 'Female patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis', 'armGroupLabels': ['Intravaginal Treatment', 'Intravaginal and intraurethral Treatment']}, {'name': 'Intraurethral Fotona SP Dynamis', 'type': 'DEVICE', 'description': 'Female patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis', 'armGroupLabels': ['Intravaginal and intraurethral Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Urology Associates', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J1L 1C6', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Exgogenia, Institute of Anti-Aging and Regenerative Medicine', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fotona d.o.o.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}