Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 10:30 PM
Study NCT ID:
NCT01366066
Status:
TERMINATED
Last Update Posted:
2013-05-24
First Post:
2011-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Failure to recruit participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-23', 'studyFirstSubmitDate': '2011-05-30', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaper test - weight (grams)', 'timeFrame': 'Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)'}], 'secondaryOutcomes': [{'measure': "Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms", 'timeFrame': 'Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)'}, {'measure': 'Treatment satisfaction', 'timeFrame': 'After 6 weeks of treatment (when treatment is terminated)'}, {'measure': 'Urethral pressure (in the stress group)', 'timeFrame': 'Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)'}, {'measure': 'Episodes of over active bladder during urodynamics (urge patients)', 'timeFrame': 'Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)'}, {'measure': 'Micturition diary - The number of involuntary incontinence and normal micturition episodes', 'timeFrame': 'Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stress incontinence', 'urge incontinence', 'overactive bladder syndrome', 'vibration', 'nerve stimulation'], 'conditions': ['Stress Urinary Incontinence', 'Urge 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 Transcutaneous Mechanical Nerve Stimulation (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 2 groups of patients with 30 patients in each group: Women suffering from urinary stress incontinence and women suffering from urge incontinence. A medical vibrator is used and in each group the subjects will be randomized to vibration treatment or no vibration treatment. All patients will receive pelvic floor training and all women suffering from urge incontinence will receive anticholinergic medications.\n\nThe stimulation will be performed at the perineum every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.\n\nIf the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators 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': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women suffering from stress incontinence OR Women suffering from urge incontinence /overactive bladder syndrome\n* Ongoing anticholinergic treatment in the urge incontinence/overactive bladder syndrome group\n* Patient capable of understanding protocol and performing treatment\n\nExclusion Criteria:\n\n* On going pregnancy or breast feeding\n* Treatment with anticholinergic medications in the stress incontinence group\n* Treatment with diuretic drugs\n* Acute illness (including infection, trauma and haematuria)\n* Fibromyalgia\n* Faecal incontinence\n* Known neurological disease\n* Bladder pain syndrome\n* Genital prolaps \\> stage 2 on the Pelvic Organ Prolapse Quantification System POP-Q\n* Previous treatment with neuromodulation or Botox\n* Previous pelvic floor surgery or radiation'}, 'identificationModule': {'nctId': 'NCT01366066', 'briefTitle': 'Transcutaneous Mechanical Nerve Stimulation 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 Stress Incontinence and Urge Incontinence', 'orgStudyIdInfo': {'id': 'H-2-2010-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TMNS treatment - Stress incontinence', 'description': 'Women with stress incontinence treated with active TMNS (vibration)', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment - stress incontinence', 'description': 'Women with stress incontinence NOT treated with TMNS (vibration)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TMNS treatment - Urge incontinence', 'description': 'Women with stress incontinence treated with TMNS (vibration)', 'interventionNames': ['Device: Transcutaneous mechanical nerve stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment - urge incontinence', 'description': 'Women with urge incontinence NOT treated with TMNS (vibration)'}], 'interventions': [{'name': 'Transcutaneous mechanical nerve stimulation', 'type': 'DEVICE', 'otherNames': ['FERTI CARE personel, Multicept A/S, Albertslund, Danmark'], '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. The stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz.\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.', 'armGroupLabels': ['TMNS treatment - Stress incontinence', 'TMNS treatment - Urge incontinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'state': 'Denmark', 'country': 'Denmark', 'facility': 'Departement of Gynecology, Roskilde Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Mikkel Fode, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital at Herlev'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zealand University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}