Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06458556
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transvaginal Radiofrequency Ablation for Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Non-blinded non-comparative pilot trial in which a total of 20 subjects with OAB are included. Subjects may include individuals with overactive balder and contraindications to alternative first- and second-line treatments, OAB and do not desire pursuing alternative first- and second-line treatments, refractory overactive balder, and urge predominate mixed urinary incontinence. Subjects will undergo treatment with the Morpheus system every 4 weeks for a total of 3 treatments. Follow up will occur at 3- month and 6-month intervals after the subjects first treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms', 'timeFrame': '3 months', 'description': 'Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region.\n\n0 = Not at all\n\n1. = Slightly\n2. = Moderately\n3. = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity.'}, {'measure': 'To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms', 'timeFrame': '3 months', 'description': 'Measured by the Incontinence Impact Questionnaire Total Score. Normative values for a general population, 10% of whom scored above 4.8 on IIQ-7. Values obtained from patients with severe incontinence indicate that a score \\> 70 on the IIQ signifies a poor QOL. Lower scores on IIQ-7 may identify more females who are bothered by urinary incontinence. 7 items are divided into four domains (physical activity, travel, social relationships, emotional health). Item-level scores are rated on a four-point Likert scale (where 0=not at all and 3=greatly), determined by the self-reported impact of symptoms related to urinary incontinence.\n\nThe average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.'}], 'secondaryOutcomes': [{'measure': 'To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life', 'timeFrame': '6 months', 'description': 'Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region.\n\n0 = Not at all\n\n1. = Slightly\n2. = Moderately\n3. = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity.'}, {'measure': 'To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life', 'timeFrame': '6 months.', 'description': 'Measured by the Incontinence Impact Questionnaire Total Score. Normative values for a general population, 10% of whom scored above 4.8 on IIQ-7. Values obtained from patients with severe incontinence indicate that a score \\> 70 on the IIQ signifies a poor QOL. Lower scores on IIQ-7 may identify more females who are bothered by urinary incontinence. 7 items are divided into four domains (physical activity, travel, social relationships, emotional health). Item-level scores are rated on a four-point Likert scale (where 0=not at all and 3=greatly), determined by the self-reported impact of symptoms related to urinary incontinence.\n\nThe average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.'}, {'measure': 'To assess the effectiveness of RF ablation assess on urgency and associated life impact', 'timeFrame': '6 months', 'description': 'Measured by the Medical, Epidemiologic, and Social Aspects of Aging (MESA ).The MESA questionnaire is consisted of 2 separate parts, with 6 questions concerning urgency urinary incontinence (UUI) and 9 concerning stress urinary incontinence (SUI).\n\nMESA SI (Stress Incontinence), theoretical scores ranged from 1 (mild) to 27 (severe).\n\nMESA UI (Urgency Incontinence), theoretical scores ranged from 1 (mild) to 18 (severe).\n\nHigher scores indicate more severe symptoms,'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women with overactive bladder', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-85 years old\n* Urinary incontinence for ≥ 3 months\n* Reporting at least "moderate bother" on Item 2 on the Urinary Distress Inventor questioner, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)\n* If mixed urinary incontinence, urge is reported predominant symptom on MESA score.\n* \\>10 micturition per 24 hours and \\>3 urgency episodes on 3-ay bladder diary\n* \\> 1 UUI episode on 3-day bladder diary\n* Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2-week wash-out period)\n\nExclusion Criteria:\n\n* Non-English speakers\n* Severely impaired mobility or cognition\n* Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson\'s Disease\n* Repair of pelvic organ prolapse in the previous 6 months\n* Received intravesical botulinum injection within the previous 12 months\n* History of implanted nerve stimulator for incontinence\n* History of prior sling or vaginal mesh placement, UNLESS onset of UUI was completely unrelated to placement and severity was unaffected by mesh placement.\n* Previous diagnosis of Interstitial cystitis\n* Active pelvic organ malignancy\n* History of pelvic radiation\n* Urethral obstruction\n* Urinary retention or prolonged catheter use\n* Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months\n* Untreated symptomatic urinary tract infection\n* Unevaluated hematuria\n* Medical instability\n* Allergy to anesthetics used in the study\n* Not available for follow-up in 6 months\n* Participation in other research trials that could influence results of this study'}, 'identificationModule': {'nctId': 'NCT06458556', 'briefTitle': 'Transvaginal Radiofrequency Ablation for Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'InMode MD Ltd.'}, 'officialTitle': 'Transvaginal Radiofrequency Ablation With Morpheus Device for Treatment of Overactive Bladder.', 'orgStudyIdInfo': {'id': 'DO613705A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with Morpheus', 'interventionNames': ['Device: Treatment with Morpheus']}], 'interventions': [{'name': 'Treatment with Morpheus', 'type': 'DEVICE', 'description': 'Radiofrequency device treatment', 'armGroupLabels': ['Treatment with Morpheus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92625', 'city': 'Corona del Mar', 'state': 'California', 'country': 'United States', 'facility': 'California Center for Pelvic Floor Disorders', 'geoPoint': {'lat': 33.59808, 'lon': -117.87311}}], 'overallOfficials': [{'name': 'Mickey Karram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Not affiliated'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InMode MD Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}