Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT02185235
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}, {'id': 'D001676', 'term': 'Biofeedback, Psychology'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-07-03', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vaginal pressure (mmHg)', 'timeFrame': 'Total 18 times of treatment, for 3 months', 'description': 'Use the vaginal probe sensor to evaluate the objective level of vaginal squeezing pressure and endurance time'}, {'measure': 'Urodynamics data analysis', 'timeFrame': 'Total 18 times of treatment, for 3 months', 'description': 'Use urodyanmic examinations for evaluation of bladder function'}], 'primaryOutcomes': [{'measure': '1-Hour Pad test of urine leakage amount (gm)', 'timeFrame': 'Total 18 times of treatment, for 3 months', 'description': 'A pad test is a tool to used to measure urine leakage amount . Pad testing can be done over a period of time to one hour.\n\nA sanitary napkin is weighed and then worn for sixty minutes, during which time the individual is asked to perform certain activities which may include:\n\n* Walking briskly for three minutes\n* Sitting and then standing ten to twenty times\n* Walking up and down stairs for one to two minutes\n* Picking up objects from the floor five to ten times\n* Coughing twelve times (at various strengths; may be repeated)\n* Running in place for one minute (may be repeated) The pad is then removed and weighed again to calculate the amount of urine voided.'}], 'secondaryOutcomes': [{'measure': 'Quality of life (score)', 'timeFrame': 'Total 18 times of treatment, for 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Electrical stimulation', 'Biofeedback'], 'conditions': ['Pelvic Organ Prolapse', 'Incontinence']}, 'referencesModule': {'references': [{'pmid': '39170685', 'type': 'DERIVED', 'citation': 'Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Effect of intra-vaginal electric stimulation on bladder compliance in stress urinary incontinence patients: the involvement of autonomic tone. Front Neurosci. 2024 Aug 7;18:1432616. doi: 10.3389/fnins.2024.1432616. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse (POP), and fecal incontinence-which often occur together.\n\nPelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women.\n\nSurgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies.\n\nThis may be because of higher awareness among women and cost of and morbidity after surgery.\n\nThe conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback.\n\nThe outcome was up to 35\\~70 % improved rate as the literature before. Current guidelines recommended conservative management as a first-line therapy. However, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies.\n\nTherefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.).\n\nAt the aspect of Quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.\n\nExclusion Criteria:\n\n* Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device'}, 'identificationModule': {'nctId': 'NCT02185235', 'briefTitle': 'A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Memorial Hospital'}, 'officialTitle': 'To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women', 'orgStudyIdInfo': {'id': '14MMHIS031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biofeedback & Electrical Stimulation', 'description': 'Twice a week, 20 minutes for each time. One course includes 18 times treatment.', 'interventionNames': ['Device: Electrical Stimulation', 'Device: Biofeedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biofeedback & Pelvic Floor Training', 'description': 'Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.', 'interventionNames': ['Device: Biofeedback', 'Other: Pelvic Floor Training']}], 'interventions': [{'name': 'Electrical Stimulation', 'type': 'DEVICE', 'otherNames': ['Femiscan Stim (Mega Electronics Ltd)'], 'description': 'The Chartered Society of Physiotherapy recommends the following standard for electrical devices.\n\nFrequency: 35 Hertz. Pulse width: 250µs (0.25ms). Current type: bi-phasic rectangular. Intensity: maximum tolerated. Duty-cycle: 5 seconds on/10 seconds off. Very weak muscles: 5 seconds on/15 seconds off.\n\nTreatment time: 5 minutes initially, gradually increasing to 20 minutes.', 'armGroupLabels': ['Biofeedback & Electrical Stimulation']}, {'name': 'Biofeedback', 'type': 'DEVICE', 'otherNames': ['Femiscan Multi-trainer'], 'description': 'Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies', 'armGroupLabels': ['Biofeedback & Electrical Stimulation', 'Biofeedback & Pelvic Floor Training']}, {'name': 'Pelvic Floor Training', 'type': 'OTHER', 'description': 'First, as you are sitting or lying down, try to contract the muscles you would use to stop urinating To contract the pelvic muscles, squeeze for 3 seconds and then relax for 3 seconds.\n\nRepeat this exercise to 20 minutes each session.', 'armGroupLabels': ['Biofeedback & Pelvic Floor Training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Taiwan, Taipei, Mackay Memorial hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tsung-Hsien Su, PhD', 'role': 'CONTACT', 'email': 'drthsu@mail.itrip.com.tw', 'phone': '886-25433535', 'phoneExt': '2544'}], 'overallOfficials': [{'name': 'TSUNG H Su, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mackay Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mackay Memorial Hospital', 'investigatorFullName': 'Tsung-Hsien Su', 'investigatorAffiliation': 'Mackay Memorial Hospital'}}}}