Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT03535857
Status:
TERMINATED
Last Update Posted:
2025-04-15
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'napoegs@upmc.edu', 'phone': '412-641-7850', 'title': 'Dr, Gnankang Sarah Napoe', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Unilateral PTNS', 'description': 'One ankle stimulation', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bilateral PTNS', 'description': 'Two ankle stimulation', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score', 'description': 'Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for one ankle stimulation'}, {'id': 'OG001', 'title': 'Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score', 'description': 'Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for two ankle stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.8', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '-23.5', 'spread': '29.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.546', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'statisticalMethod': 'Pairwise t- test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks or last measurement', 'description': 'Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores.\n\nThe investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral PTNS Change in Number of Daily Voids', 'description': 'Change in number of voids defined as number of voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of voids for unilateral stimulation'}, {'id': 'OG001', 'title': 'Bilateral PTNS Change in Number of Daily Voids', 'description': 'Change in number of voids defined as number of voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of voids for bilateral stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks or last measurement', 'description': 'The change in number of voids was obtained by comparing number of voids at 12 weeks or last measurement compared to baseline number of voids.', 'unitOfMeasure': 'Number of daytime voids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.'}, {'type': 'SECONDARY', 'title': 'Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral PTNS Change in Number of Incontinence Episodes', 'description': 'Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes for one ankle stimulation'}, {'id': 'OG001', 'title': 'Bilateral PTNS Change in Number of Incontinence Episodes Per 24 Hours', 'description': 'Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes for two ankle stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks or last measurement', 'description': 'Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes.', 'unitOfMeasure': 'Number of incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.'}, {'type': 'SECONDARY', 'title': 'Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral PTNS Nocturia Episodes at Last Measurement', 'description': 'Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids for one ankle stimulation'}, {'id': 'OG001', 'title': 'Bilateral PTNS Nocturia Episodes at Last Measurement', 'description': 'Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids for two ankle stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks or last measurement', 'description': 'Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids.', 'unitOfMeasure': 'Number of nighttime voids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.'}, {'type': 'SECONDARY', 'title': 'Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral PTNS Incontinence Impact Questionnaire-7 Score Change', 'description': 'Impact of treatment on quality of life was measured by comparing the last incontinence impact questionnaire score to the baseline incontinence impact questionnaire score for one ankle stimulation'}, {'id': 'OG001', 'title': 'Bilateral PTNS Incontinence Impact Questionnaire-7 Score Change', 'description': 'Impact of treatment on quality of life was measured by comparing the last incontinence impact questionnaire score to the baseline incontinence impact questionnaire score for two ankle stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.8', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '-19.3', 'spread': '18.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks or last measurement', 'description': 'The incontinence impact questionnaire was used to measure the impact on quality of life. The questionnaire score ranges from 0 to 100 with higher scores indicating worse quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unilateral PTNS', 'description': '34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period\n\nPTNS: Use of PTNS on the ankle for 30 minutes'}, {'id': 'FG001', 'title': 'Bilateral PTNS', 'description': '34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period\n\nPTNS: Use of PTNS on the ankle for 30 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Unilateral PTNS', 'description': 'PTNS: Use of PTNS on the ankle for 30 minutes'}, {'id': 'BG001', 'title': 'Bilateral PTNS', 'description': 'PTNS: Use of PTNS on both ankles for 30 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.1', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '69.4', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'On Overactive bladder (OAB) Medications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Diabetes mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Overactive bladder questionnaire short form (OABq SF) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.6', 'spread': '21.6', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '26.2', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '24.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}, {'title': 'Incontinence Impact Questionnaire (IIQ) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.5', 'spread': '29.7', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '23.6', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '26.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}, {'title': 'Daily Incontinence Episodes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Incontinence episodes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}, {'title': 'Nocturia Episodes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Nocturia episodes', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}, {'title': 'Daily voids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '9.6', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '9.7', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Daily voids', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-30', 'size': 158210, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-07T14:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Challenges with recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2018-05-08', 'resultsFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-20', 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement', 'timeFrame': '12 weeks or last measurement', 'description': 'Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores.\n\nThe investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.'}], 'secondaryOutcomes': [{'measure': 'Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement', 'timeFrame': '12 weeks or last measurement', 'description': 'The change in number of voids was obtained by comparing number of voids at 12 weeks or last measurement compared to baseline number of voids.'}, {'measure': 'Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement', 'timeFrame': '12 weeks or last measurement', 'description': 'Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes.'}, {'measure': 'Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement', 'timeFrame': '12 weeks or last measurement', 'description': 'Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids.'}, {'measure': 'Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement', 'timeFrame': '12 weeks or last measurement', 'description': 'The incontinence impact questionnaire was used to measure the impact on quality of life. The questionnaire score ranges from 0 to 100 with higher scores indicating worse quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['overactive bladder', 'OAB', 'urge urinary incontinence', 'PTNS'], 'conditions': ['Overactive Bladder Syndrome', 'Urinary Incontinence, Urge']}, 'referencesModule': {'references': [{'pmid': '41342952', 'type': 'DERIVED', 'citation': 'Napoe GS, Hall E, Dasgupta P, Myers DL, Wohlrab KJ. Randomized trial of unilateral versus bilateral percutaneous tibial nerve stimulation for the treatment of overactive bladder. World J Urol. 2025 Dec 4;44(1):15. doi: 10.1007/s00345-025-06107-0.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence', 'detailedDescription': 'Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy\n2. Patients who consent to participate in the study\n3. Patients on pharmacologic therapy at the time of recruitment can continue their treatment\n\nExclusion Criteria:\n\n1. Pregnant patients\n2. Patients with pacemakers of implantable defibrillators\n3. Patients with neurogenic bladder\n4. Patients who have received Botox or have an implant for sacral nerve stimulation\n5. Patients with uncontrolled bleeding disorder\n6. Patients with unhealed ulcers or with leg edema surrounding medial malleolus'}, 'identificationModule': {'nctId': 'NCT03535857', 'acronym': 'BUTTON', 'briefTitle': 'Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence', 'orgStudyIdInfo': {'id': 'STUDY19100230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unilateral PTNS', 'description': '34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period', 'interventionNames': ['Device: PTNS']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral PTNS', 'description': '34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period', 'interventionNames': ['Device: PTNS']}], 'interventions': [{'name': 'PTNS', 'type': 'DEVICE', 'description': 'Use of PTNS on the ankle for 30 minutes', 'armGroupLabels': ['Bilateral PTNS', 'Unilateral PTNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Gnankang Sarah Napoe', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'WIHRI', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'G. Sarah Napoe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Kyle Wohlrab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Women and Infants Hospital of Rhode Island'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gnankang Sarah Napoe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gnankang Sarah Napoe', 'investigatorAffiliation': 'University of Pittsburgh'}}}}