Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
Study NCT ID:
NCT03969368
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2019-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of quality of life improvement using the UDI-6 questionnaire', 'timeFrame': '13 months', 'description': 'Evaluation of change in UDI-6 score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.'}, {'measure': 'Evaluation of incontinence episodes using Bladder diary', 'timeFrame': '13 months', 'description': 'Evaluation of change in incontinence episodes before and after the study treatment in both study groups.'}, {'measure': 'Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire', 'timeFrame': '13 months', 'description': 'Evaluation of change in ICIQ-LUTSqol score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.'}, {'measure': 'Evaluation of quality of life improvement using the Pad Usage Questionnaire', 'timeFrame': '13 months', 'description': 'Evaluation of change in Pad Usage Questionnaire before and after the study treatment in both study groups. Decrease in number of used pads will be considered as an improvement.'}, {'measure': 'Evaluation of pelvic floor muscle strength', 'timeFrame': '13 months', 'description': 'Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.'}], 'secondaryOutcomes': [{'measure': 'Subject Satisfaction evaluation', 'timeFrame': '13 months', 'description': "Qualitative analysis of subject's opinion using a questionnaire. Subjects will be asked to describe the change and their satisfaction after the study treatment."}, {'measure': 'Therapy comfort evaluation', 'timeFrame': '1 month', 'description': 'Evaluation of therapy comfort after each treatment or training session using the questionnaire.'}, {'measure': 'Safety evaluation', 'timeFrame': '13 months', 'description': 'Incidence of adverse events (AE) associated with study device will be followed.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged 25-70 years\n* Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)\n* Voluntarily signed informed consent form\n* Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure\n* Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study\n\nExclusion Criteria:\n\n* Use of Botox® in the bladder or pelvic muscles in the last year\n* Use of Interstim® or similar device for the treatment of UI\n* Suffers from other types of urinary incontinence other than SUI, UUI, MUI\n* Pelvic organ prolapse grade 2 and higher\n* Pronounced lesions of the pudendus nerve during clinical neurophysiological examination\n* Currently lactating\n* Cardiac pacemakers\n* Implanted defibrillators and/or neurostimulators\n* Electronic implants\n* Metal implants, including copper IUD\n* Drug pumps\n* Hemorrhagic conditions\n* Anticoagulation therapy\n* Fever\n* Pregnancy\n* Following recent surgical procedures when muscle contraction may disrupt the healing process\n* Application over areas of the skin which lack normal sensation\n* Any disorders that the Investigator deems would interfere with study endpoints or subject safety'}, 'identificationModule': {'nctId': 'NCT03969368', 'briefTitle': 'rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'BTL Industries Ltd.'}, 'officialTitle': 'Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence', 'orgStudyIdInfo': {'id': 'BTL-099-U2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Treatment with the investigational device - rPMS', 'interventionNames': ['Device: rPMS device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Control group', 'interventionNames': ['Procedure: Pelvic floor muscle training']}], 'interventions': [{'name': 'rPMS device', 'type': 'DEVICE', 'description': 'Pelvic floor muscle contractions will be induced by the rPMS device.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Pelvic floor muscle training', 'type': 'PROCEDURE', 'description': 'Control group will undergo a pelvic floor muscle training', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02481', 'city': 'Wellesley', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Urogyn', 'geoPoint': {'lat': 42.29649, 'lon': -71.29256}}, {'zip': '08873', 'city': 'Somerset', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Center for Urogynecology and Reconstructive Surgery', 'geoPoint': {'lat': 40.4976, 'lon': -74.48849}}, {'zip': '18940', 'city': 'Newtown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Female Pelvic Health Center', 'geoPoint': {'lat': 40.22928, 'lon': -74.93683}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Female Pelvic Medicine Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BTL Industries Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}