Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT00695058
Status:
WITHDRAWN
Last Update Posted:
2012-02-24
First Post:
2008-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Failure to include', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-23', 'studyFirstSubmitDate': '2008-06-09', 'studyFirstSubmitQcDate': '2008-06-10', 'lastUpdatePostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaper test - weight (grams); Micturition diary - The number of involuntary incontinence and normal micturition episodes; Amplitude of vibration (mm) and pressure (cm H2O) in the external sphincter of the urethra', 'timeFrame': 'Before treatment, after treatment and at follow up'}], 'secondaryOutcomes': [{'measure': "Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms", 'timeFrame': 'before treatment, after treatment and at follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stress incontinence', 'urge incontinence', 'overactive bladder syndrome', 'vibration', 'nerve stimulation'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that TMNS in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome.\n\nThe present study aims to treat urinary incontinence and includes 3 groups of patients with 40 patients in each group: Women suffering from urinary stress incontinence, women suffering from urge incontinence and men suffering from urinary incontinence after a prostatectomy. A medical vibrator is used and in each group the subjects will be randomized to active treatment or placebo treatment.\n\nIn women the stimulation will be performed at the perineum every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. In men the vibration parameter/location will be determined by the results of a pressure profile study also included. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.\n\nIf we are able to demonstrate a significant reduction in the incontinence symptoms in the subjects we asses that vibration can be a way of reestablishing a normal function of the pelvic floor muscles and bladder function in incontinent patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women suffering from stress incontinence\n* Women suffering from overactive bladder syndrome\n* Men who are still incontinent at a minimum of one year after a radical prostatectomy\n\nExclusion Criteria:\n\n* Pregnant and nursing women will not be included in the study'}, 'identificationModule': {'nctId': 'NCT00695058', 'acronym': 'TMNS', 'briefTitle': 'Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence', 'orgStudyIdInfo': {'id': 'H-B-2007-047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Women with stress incontinence treated with active TMNS (vibration)', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Women with stress incontinence treated with placebo TMNS (vibration)with an amplitude of 0', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Women with overactive bladder syndrome treated with active TMNS (vibration)', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Women with overactive bladder syndrome treated with placebo TMNS (vibration)with an amplitude of 0', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'males who are still incontinent at a minimum of one year after a radical prostatectomy treated with active TMNS (vibration)', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '6', 'description': 'males who are still incontinent at a minimum of one year after a radical prostatectomy treated with placebo TMNS (vibration)with an amplitude of 0', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)']}], 'interventions': [{'name': 'Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)', 'type': 'DEVICE', 'description': 'A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the perineum in women and the perineum or the frenulum in men.\n\nIn the women the stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz. In the men the vibration parameter/location will be determined by the results of the new pressure profile studies (aim 3).\n\nA daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks in both the women with stress incontinence and overactive bladder syndrome.\n\nIn the 3 groups of patients the subjects will be randomized to either active treatment or placebo treatment. The placebo treatment will be done with a vibration device with an amplitude of 0 mm. Subjects will be randomized by a draw.', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Department of Urology, University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': 'DK 2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Urology, Herlev University Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'The Regional Hospital of Viborg', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Jens R Sonksen, MD, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Copenhagen University Hospital at Herlev'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mikkel Fode/medical student', 'oldOrganization': 'Copenhagen University Hospital at Herlev'}}}}