Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-19 @ 10:42 PM
Study NCT ID:
NCT02452593
Status:
UNKNOWN
Last Update Posted:
2015-05-22
First Post:
2015-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-12-19', 'releaseDate': '2016-10-26'}, {'resetDate': '2017-03-03', 'releaseDate': '2017-01-16'}, {'resetDate': '2018-01-26', 'releaseDate': '2017-06-28'}], 'estimatedResultsFirstSubmitDate': '2016-10-26'}}, 'conditionBrowseModule': {'meshes': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Urinary incontinence', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['incontinence; pelvic floor exercises; neuromodulation'], 'conditions': ['Urge Incontinence']}, 'descriptionModule': {'briefSummary': "Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women's lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency.\n\nThe overactive bladder present in urge incontinence and mixed cause significant impacts on people's lives and has a prevalence of 16.5% in the US population.\n\nBehavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment. Drug therapy using drugs which are not specific for the bladder and are associated with many unwanted systemic side effects.\n\nThe results obtained by researchers in several countries using conservative techniques in the treatment of patients with urinary incontinence are encouraging and this study aims to evaluate carefully and systematically the effectiveness of tibial stimulation technique.\n\nImportantly, also, that conservative techniques have lower cost than the surgical treatment and have virtually no side effects as most of the drugs used in the pharmacological treatment of female urinary incontinence.", 'detailedDescription': 'Goal\n\nDevelopment of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using tibial stimulation and pelvic floor exercises.\n\nSecondary objectives\n\n* Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point).\n* Comparison of the effectiveness of tibial stimulation techniques and pelvic floor exercises in the treatment of overactive bladder and urgency / mixed incontinence.\n\nDesign Randomized Clinical Trial\n\nSample Women over the age of 18, complaining of urinary incontinence Urgency or Mixed (with main urgency component), catered in Urogynecology Ambulatory of Hospital de Clinicas de Porto Alegre.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Women with Urinary Incontinence of Urgency or Mixed older than 18 years\n\nExclusion Criteria:\n\n* Presence Of vaginal or urinary infection\n* Not understand or sign the informed consent\n* Not understand or are unable to perform the proposed treatment\n* Pregnancy or the postpartum period covering the period up to 6 months after delivery\n* Women in previous use of chronically used drugs (antidepressants, diuretics, and others) that can evidently alter the urinary function.\n* Stress Urinary Incontinence of pure or mixed incontinence with a predominance of Stress component neurogenic bladder\n* Use of Botox® in the bladder or pelvic muscles in the last year\n* Use Interstim® or Bion®\n* Use pacemaker or implantable defibrillator\n* Current use of TENS in the pelvic region, lower back or legs\n* Previous use of percutaneous tibial stimulation\n* Drug / experimental devices in the past 4 weeks,\n* Participation in any clinical research involving or affecting the urinary or renal function in the last 4 weeks.\n* Pelvic radiotherapy;\n* Changes in sensibility Lower Limb;'}, 'identificationModule': {'nctId': 'NCT02452593', 'briefTitle': 'Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Rio Grande do Sul'}, 'officialTitle': 'Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder, Urge and Mixed Urinary Incontinence', 'orgStudyIdInfo': {'id': 'UFRGSDGO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '"Tibial Nerve Stimulation"', 'description': 'This group will do transcutaneous electrical stimulation of the tibial nerve at home.\n\nDevelopment of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point). Frequency: 20 Hz, Pulse width: 200 us; duration: 15min daily', 'interventionNames': ['Other: "Tibial stimulation" and "pelvic floor exercises"']}, {'type': 'ACTIVE_COMPARATOR', 'label': '"Pelvic Floor Exercises"', 'description': 'This group will make pelvic muscle training 3 times a day . In decubit dorsal posture, legs flexed and abductee. Perform pelvic floor contractions keeping 2 seconds and relaxing 4 seconds for 10 times, and contractions keeping 4 seconds and relaxing 8 seconds for 10 times.', 'interventionNames': ['Other: "Tibial stimulation" and "pelvic floor exercises"']}], 'interventions': [{'name': '"Tibial stimulation" and "pelvic floor exercises"', 'type': 'OTHER', 'description': 'A group will make tibial nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks', 'armGroupLabels': ['"Pelvic Floor Exercises"', '"Tibial Nerve Stimulation"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Magda Aranchipe', 'role': 'CONTACT', 'email': 'mchipe@hotmail.com'}], 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Magda Ms Aranchipe, Master', 'role': 'CONTACT', 'email': 'mchipe@hotmail.com'}, {'name': 'Luciana Dr Paiva, PhD', 'role': 'CONTACT', 'email': 'luciana.paiva@ufrgs.br'}], 'overallOfficials': [{'name': 'Jose Geraldo Dr Ramos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Magda da Silva Aranchipe', 'investigatorAffiliation': 'Federal University of Rio Grande do Sul'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-10-26', 'type': 'RELEASE'}, {'date': '2016-12-19', 'type': 'RESET'}, {'date': '2017-01-16', 'type': 'RELEASE'}, {'date': '2017-03-03', 'type': 'RESET'}, {'date': '2017-06-28', 'type': 'RELEASE'}, {'date': '2018-01-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hospital de Clinicas de Porto Alegre'}}}}