Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:01 AM
Study NCT ID:
NCT01783392
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2013-01-31', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in frequency of voiding', 'timeFrame': 'baseline, 4 weeks', 'description': 'The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.'}, {'measure': 'Change in Patient Perception of Bladder Condition (PPBC)', 'timeFrame': 'baseline, 4 weeks', 'description': "Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment."}], 'secondaryOutcomes': [{'measure': 'Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire', 'timeFrame': 'baseline, 4 weeks', 'description': 'Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment.'}, {'measure': 'Changes in the mental/physical scores of RAND36', 'timeFrame': 'baseline, 4 weeks'}, {'measure': 'Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire', 'timeFrame': 'baseline, 4 weeks', 'description': 'Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment'}]}, 'conditionsModule': {'keywords': ['overactive bladder', 'transcutaneous posterior tibial nerve stimulation', 'placebo PTNS'], 'conditions': ['Idiopathic Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and Females, at least 18 years of age\n* Documented symptoms of idiopathic overactive bladder for at least 3 months\n* Failure on primary OAB treatment, such as behavior modification or fluid/diet management\n* Patients can remain on stable medication\n* Willing and capable of understanding and complying with all requirements of the protocol\n* Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits\n\nExclusion Criteria:\n\n* Urinary retention or post voiding residual greater than 100 ml\n* Clinically significant bladder outlet obstruction\n* Stress predominant mixed urinary incontinence\n* Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury.\n* Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months\n* Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months\n* Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months\n* Any form of electric stimulation to the pelvis or lower limbs within 4 weeks\n* Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria.\n* Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months.\n* History of pelvic radiation therapy\n* Any skin conditions affecting treatment sites\n* Lacking dexterity to properly utilize the components of the stimulator system.\n* Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),\n* Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.\n* Recurrent Urinary Tract Infections UTI (\\>3 UTI's in the past year)\n* History of, or current, lower tract genitourinary malignancies\n* Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study\n* Any other clinical trial within 6 months"}, 'identificationModule': {'nctId': 'NCT01783392', 'acronym': 'PESTOB', 'briefTitle': 'Peripheral Electrical Stimulation for the Treatment of Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Peripheral Electrical Stimulation for the Treatment of Overactive Bladder', 'orgStudyIdInfo': {'id': 'STH16245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unilateral Posterior Tibial Nerve Stimulation', 'description': 'Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve and sets the stimulation intensity to a comfortable level.', 'interventionNames': ['Procedure: Transcutaneous Electrical Nerve Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral Posterior Tibial Nerve Stimulation', 'description': 'Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve on both legs and sets the stimulation intensity to a comfortable level.', 'interventionNames': ['Procedure: Transcutaneous Electrical Nerve Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shoulder stimulation', 'description': 'Stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode and the anode electrodes on the lateral side of the left shoulder.', 'interventionNames': ['Procedure: Transcutaneous Electrical Nerve Stimulation']}], 'interventions': [{'name': 'Transcutaneous Electrical Nerve Stimulation', 'type': 'PROCEDURE', 'armGroupLabels': ['Bilateral Posterior Tibial Nerve Stimulation', 'Shoulder stimulation', 'Unilateral Posterior Tibial Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2JF', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Christopher Chapple', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}