Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT03520166
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2018-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Medium Frequency Electrotherapy in the Treatment of OAB, LUTS and Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], '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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-15', 'size': 436661, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-25T14:26', 'hasProtocol': False}, {'date': '2014-01-08', 'size': 361400, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-26T02:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Type inclusion was consecutively type'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Quasi-experimental, longitudinal, pre-/post-. Level of evidence II/III.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urgency', 'timeFrame': '24 hours', 'description': 'with or without urge incontinence, usually with frequency and nocturia, can be described as the overactive bladder syndrome, urge syndrome or urgency-frequency syndrome. Measured with 24 hour voiding diary.'}], 'secondaryOutcomes': [{'measure': 'urge urinary incontinence', 'timeFrame': '24 hours', 'description': 'is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Measured with 24 hour voiding diary.'}, {'measure': 'increased daytime frequency', 'timeFrame': '24 hours', 'description': 'is the complaint by the patient who considers that he/she voids too often by day. Measured with 24 hour voiding diary.'}, {'measure': 'nocturia', 'timeFrame': '24 hours', 'description': 'is the complaint that the individual has to wake at night one or more times to void. Measured with 24 hour voiding diary.'}, {'measure': 'increased bladder sensation', 'timeFrame': '24 hours', 'description': 'the individual feels an early and persistent desire to void. Measured with 24 hour voiding diary.'}, {'measure': 'feeling of incomplete emptying', 'timeFrame': '24 hours', 'description': 'is a self-explanatory term for a feeling experienced by the individual after passing urine. Measured with 24 hour voiding diary.'}, {'measure': 'nocturnal enuresis', 'timeFrame': '24 hours', 'description': 'is the complaint of loss of urine occurring during sleep. Measured with 24 hour voiding diary.'}, {'measure': 'incontinence', 'timeFrame': '24 hours', 'description': 'is the complaint of any involuntary leakage of urine. Measured with 24 hour voiding diary.'}, {'measure': 'pelvic pain', 'timeFrame': '24 hours', 'description': 'is less well defined than, for example, bladder, urethral or perineal pain and is less clearly related to the micturition cycle or to bowel function and is not localised to any single pelvic organ. Measured with pain visual analogic pain scale single-item scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urgency', 'frequency', 'overactive bladder', 'LUTS', 'pelvic pain', 'electrostimulation'], 'conditions': ['Urinary Bladder, Overactive', 'Lower Urinary Tract Symptoms', 'Pelvic Pain']}, 'referencesModule': {'references': [{'pmid': '29426587', 'type': 'BACKGROUND', 'citation': 'Almeida CC, Silva VZMD, Junior GC, Liebano RE, Durigan JLQ. Transcutaneous electrical nerve stimulation and interferential current demonstrate similar effects in relieving acute and chronic pain: a systematic review with meta-analysis. Braz J Phys Ther. 2018 Sep-Oct;22(5):347-354. doi: 10.1016/j.bjpt.2017.12.005. Epub 2018 Feb 2.'}, {'pmid': '12559262', 'type': 'RESULT', 'citation': 'Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effectiveness of medium frequency electrotherapy (interferential currents) treatment for overactive bladder (OAB), lower urinary tract symptoms (LUTS) and pelvic pain', 'detailedDescription': 'This study consists of 100 women, complaining of increased bladder sensation and urgency with or without incontinence as principal symptomatology and who had not received previous pharmacological treatment. Group-A was used as a control group (n = 50). Group-B patients received 18 sessions of medium frequency electrotherapy during 9 weeks, 2 weekly sessions'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIncreased bladder sensation Urgency Overactive bladder Lower urinary tract symptoms Pelvic pain\n\nExclusion Criteria:\n\nNeurogenic bladder Acute urinary infection Pelvic floor surgery Congenital urological malformations Age less than 18 years Bladder organic pathology Pelvic radiotherapy'}, 'identificationModule': {'nctId': 'NCT03520166', 'briefTitle': 'Use of Medium Frequency Electrotherapy in the Treatment of OAB, LUTS and Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Fisioterapia Pélvica Avanzada Madrid, SRL'}, 'officialTitle': 'Treatment of Overactive Bladder, Lower Urinary Tract Symptoms and Pelvic Pain With Medium Frequency Electrotherapy (Interferential Currents)', 'orgStudyIdInfo': {'id': 'FPA01/2014'}, 'secondaryIdInfos': [{'id': '1.010.817', 'type': 'OTHER_GRANT', 'domain': 'FUNDACION ALFONSO X'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group-A', 'description': 'No treatment', 'interventionNames': ['Other: No treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Group-B', 'description': 'Medium frequency electrotherapy (interferential currents)', 'interventionNames': ['Other: Medium frequency electrotherapy (interferential currents)']}], 'interventions': [{'name': 'Medium frequency electrotherapy (interferential currents)', 'type': 'OTHER', 'description': 'Treatment with medium frequency electrotherapy, interferential currents between 5500 Hz and 8500 Hz (Combi-200®, Gymna®), was performed using transvaginal application. The frequency was increased progressively over the first six sessions (twice a week), starting with a frequency of 5500 Hz until reaching a frequency of 8500 Hz, which remained until the end of treatment.', 'armGroupLabels': ['Group-B']}, {'name': 'No treatment', 'type': 'OTHER', 'description': 'No treatment', 'armGroupLabels': ['Group-A']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Cristina Naranjo-Ortiz, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fisioterapia Pelvica Avanzada Madrid, SRL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisioterapia Pélvica Avanzada Madrid, SRL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cristina Naranjo Ortiz', 'investigatorAffiliation': 'Fisioterapia Pélvica Avanzada Madrid, SRL'}}}}