Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT02657057
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2015-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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': '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'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2015-12-20', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints', 'timeFrame': '12 weeks', 'description': 'A number of at least 50% was regarded significant'}, {'measure': 'Number of complaints OR adverse effects registered during treatments', 'timeFrame': 'From Baseline to week 12', 'description': 'complaints and side effects were registered'}], 'primaryOutcomes': [{'measure': 'Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks', 'timeFrame': '12 weeks', 'description': 'A reduction in urinary frequency was regarded clinically significant when a normal voiding pattern of less than 8 voids per 24 hours could be obtained'}], 'secondaryOutcomes': [{'measure': 'Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks', 'timeFrame': '6 and 12 weeks', 'description': 'A reduction in the number of leakage episodes of at least 30% on 3-day voiding was regarded significant'}, {'measure': 'Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks', 'timeFrame': '6 and 12 weeks', 'description': 'A reduction in number of urgency episodes at 6 weeks and 12 weeks'}, {'measure': 'Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks', 'timeFrame': '6 and 12 weeks', 'description': 'A reduction of at least 25% was regarded significant'}, {'measure': 'Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)', 'timeFrame': '6 and 12 weeks', 'description': 'An improvement of at least 10 points was regarded significant'}, {'measure': 'Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks', 'timeFrame': '6 and 12 weeks', 'description': 'An improvement of at least 10 points was regarded significant'}, {'measure': 'Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks', 'timeFrame': '6 and 12 weeks', 'description': 'A score of 1 or 2 was regarded significant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neuromodulation', 'electrical estimulation', 'percutaneous', 'transcutaneous', 'OAB'], 'conditions': ['Overactive Bladder', 'Urge Incontinence', 'Overactive Detrusor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.', 'detailedDescription': "Both therapies have been proven to be effective, but very few times have been compared. PTNS and TENS SNS have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. Only PTNS has shown changes in urodynamic data while undergoing therapy.\n\nThe investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the TENS group, if we compare both therapies in a randomized control trial.\n\nSecondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at TBS scale, while undergoing these therapies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female and male\n* Age \\>18 years\n* Complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)\n* Urodynamic data of overactive detrusor\n* Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)\n* Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication\n* Willing to complete study questionnaires and informed consent study\n\nExclusion Criteria:\n\n* Presence of bladder obstruction (prostate or prolapse)\n* Neurogenic bladder overactivity\n* Previous pelvic organ prolapse surgery\n* Unwilling and mentally incompetent to participate in study\n* Pregnancy or planning to become pregnant during the study\n* Presence of urinary fistula\n* Recurrent or current urinary tract infection (5 or more infections in the last 12 months)\n* Bladder stones\n* Bladder cancer or suspected bladder cancer\n* Hematuria\n* Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion\n* Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg).\n* Uncontrolled diabetes and diabetes with peripheral nerve involvement\n* Anticoagulants treatment\n* Current use of anticholinergics or use within the last 4 weeks\n* Current use of botox bladder injections or bladder botox injection within the last year\n* Current use of interstim therapy or currently implanted interstim device or leads\n* Urinary retention or gastric retention\n* Painful Bladder Syndrome/Interstitial Cystitis\n* Previous PTNS treatment"}, 'identificationModule': {'nctId': 'NCT02657057', 'briefTitle': 'Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Médico Tecnológico SL'}, 'officialTitle': 'Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IMT46681770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Tibial Nerve Stimulation', 'description': 'TENS SNS therapy is performed as follows; patient is asked to sit with legs slightly bent and an adhesive electrode is attached transcutaneously 5cm cephalic to either the right or left medial malleolus (subject choice). A surface electrode is placed on the medial surface of the ipsilateral calcaneum and both electrodes are connected to a low voltage electronic stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy.', 'interventionNames': ['Device: TENS SNS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous Tibial Nerve Stimulation', 'description': 'PTNS therapy is performed as follows; patient is asked to sit with legs slightly bent. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial surface of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage electrical stimulator. The current is then set to the highest level tolerable to the subject (0-20 mA) and the subject undergoes therapy for 30 minutes and 12 weeks (once-a-week session). Data are completed at baseline, after half therapy and after 12 weeks therapy.', 'interventionNames': ['Device: PTNS']}], 'interventions': [{'name': 'PTNS', 'type': 'DEVICE', 'otherNames': ['Percutaneous Tibial Nerve Stimulation (URO stim2)'], 'description': 'The needle and electrode are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.', 'armGroupLabels': ['Percutaneous Tibial Nerve Stimulation']}, {'name': 'TENS SNS', 'type': 'DEVICE', 'otherNames': ['Transcutaneous Tibial Nerve Stimulation (URO stim2)'], 'description': 'Electrodes are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.', 'armGroupLabels': ['Transcutaneous Tibial Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08024', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Inés Ramírez', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Inés Ramírez, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Médico Tecnológico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Médico Tecnológico SL', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ramon Llull', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist, MSc', 'investigatorFullName': 'Inés Ramírez García', 'investigatorAffiliation': 'Instituto Médico Tecnológico SL'}}}}