Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT03547518
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2018-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.giordano@corewellhealth.org', 'phone': '248-551-3517', 'title': 'Jennifer Giordano, RN BSN Clinical Research Manager', 'organization': 'William Beaumont Hosptial'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 12 weeks in active treatment group and sham treatment groups. Sham patients that continued to the open label active PTNS treatment phase were monitored for 12 weeks.', 'description': 'Adverse events were collected at each visit by asking the participant if there were any changes to their medical history, hospitalizations, or new acute conditions.', 'eventGroups': [{'id': 'EG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Open Label Active PTNS Treatment', 'description': 'Sham participants that continued to the open label active PTNS treatment phase.\n\nOne- week induction consisting of three active PTNS treatments, each 2 hours long.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Atypical Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthmatic bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection (UTI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right lower extremity cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right lower extremity tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in GRA for Overall Bladder Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One week post induction (+/- 3 days)', 'description': 'Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One active treatment subject did not complete primary outcome'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Urinary Frequency on 3 Day Voiding Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '6.21', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '5.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week post induction (+/- 3 days)', 'description': 'Change in number of total voids as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urinary frequency from baseline, negative change means increase in urinary frequency from baseline.', 'unitOfMeasure': 'number of voids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 active treatment subject did not complete the diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Nocturia in 3 Day Voiding Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.64', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '4.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.487', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and one week post induction (+/- 3 days)', 'description': 'Change in number of total night time urinary voids over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in number of night time voids. Negative change means increase in number of night time voids.', 'unitOfMeasure': 'number of night time voids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 active subject did not complete the diary'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Degree of Urgency in 3 Day Voiding Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}], 'classes': [{'categories': [{'measurements': [{'value': '4.82', 'spread': '9.42', 'groupId': 'OG000'}, {'value': '-4.38', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0393', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week post induction (+/- 3 days)', 'description': 'Change in number of urinary voids recorded as urgent over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (end of treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.', 'unitOfMeasure': 'number of voids recorded as urgent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 active subject did not complete the diary'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '2', 'spread': '6.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.242', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and one week post induction (+/- 3 days)', 'description': 'Change in number of urge incontinence episodes over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.', 'unitOfMeasure': 'number of urge incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 active subject did not complete a diary'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}], 'classes': [{'categories': [{'measurements': [{'value': '17.73', 'spread': '18.41', 'groupId': 'OG000'}, {'value': '18.97', 'spread': '14.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.855', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week post induction (+/- 3 days)', 'description': 'Change from baseline in total score on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal. Score range 0-100. Higher score equals worse overactive bladder symptoms. Positive change means improvement in OAB symptoms. Negative change means worsening of OAB symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 active subject did not complete OABq at one week visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'FG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was primarily through physician referrals from private urology clinics. Recruitment began in March 2018 and concluded in May 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active PTNS Treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long\n\nPTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'BG001', 'title': 'Sham Treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long\n\nSham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.77', 'spread': '10.08', 'groupId': 'BG000'}, {'value': '60.75', 'spread': '8.01', 'groupId': 'BG001'}, {'value': '62.32', 'spread': '9.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-21', 'size': 286301, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-16T14:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant blinded to interventional or sham treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, single blind parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2018-05-24', 'resultsFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-21', 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in GRA for Overall Bladder Symptoms', 'timeFrame': 'One week post induction (+/- 3 days)', 'description': 'Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Urinary Frequency on 3 Day Voiding Diary', 'timeFrame': 'Baseline and 1 week post induction (+/- 3 days)', 'description': 'Change in number of total voids as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urinary frequency from baseline, negative change means increase in urinary frequency from baseline.'}, {'measure': 'Change From Baseline Nocturia in 3 Day Voiding Diary', 'timeFrame': 'Baseline and one week post induction (+/- 3 days)', 'description': 'Change in number of total night time urinary voids over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in number of night time voids. Negative change means increase in number of night time voids.'}, {'measure': 'Change From Baseline in Degree of Urgency in 3 Day Voiding Diary', 'timeFrame': 'Baseline and 1 week post induction (+/- 3 days)', 'description': 'Change in number of urinary voids recorded as urgent over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (end of treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.'}, {'measure': 'Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary', 'timeFrame': 'Baseline and one week post induction (+/- 3 days)', 'description': 'Change in number of urge incontinence episodes over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.'}, {'measure': 'Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)', 'timeFrame': 'Baseline and 1 week post induction (+/- 3 days)', 'description': 'Change from baseline in total score on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal. Score range 0-100. Higher score equals worse overactive bladder symptoms. Positive change means improvement in OAB symptoms. Negative change means worsening of OAB symptoms.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Urinary Urgency', 'Urinary Frequency', 'Urge Incontinence'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.', 'detailedDescription': 'Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9% in the United States and has been found to increase with age. OAB has a negative impact on health related quality of life (QoL), Per American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global response assessments (GRA) compared to 20.9% of sham subjects (p \\<0.001). PTNS subjects also had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is also early data from an implanted chronic tibial nerve stimulation lead study that shows a minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in incontinence episodes per day at one week. Our study will test the concept of whether the PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical improvement after a one week induction course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women and men \\> 18 years of age\n* Self-reported failed conservative care of behavioral modifications and/or oral medications\n* An above normal urinary frequency as recorded on initial 3-day voiding diary\n* Self-reported bladder symptoms greater than or equal to 3 months\n* On a stable dose of antimuscarinics/beta-3 agonists for greater than or equal to 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for greater than or equal to 2 weeks\n* Capable of giving informed consent\n* Ambulatory and able to use toilet independently without difficulty\n* Capable and willing to follow all study-related procedures\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant during study duration\n* Diagnosis of neurogenic bladder\n* Botox use in bladder or pelvic floor muscles within past 12 months\n* Pacemakers or implantable defibrillators\n* Current urinary tract infection\n* Active use of neuromodulation in any other form. If patient has InterStim, must be turned off for 2 weeks for a washout period and remain off during the entirety of the study.\n* Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region, back or legs\n* Previous PTNS treatment who received greater than 6 treatments. Those who have received less than 6 treatments will be allowed to screen if the last treatment was at least 6 months prior to screening.\n* Use of investigational drug/device therapy within past 4 weeks\n* Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks\n* Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results\n\nNote: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial."}, 'identificationModule': {'nctId': 'NCT03547518', 'briefTitle': 'Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation', 'orgStudyIdInfo': {'id': '2017-497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active PTNS treatment', 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long', 'interventionNames': ['Device: PTNS treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment', 'description': 'One-week induction consisting of three sham treatments, each 2 hours long', 'interventionNames': ['Device: Sham treatment']}], 'interventions': [{'name': 'PTNS treatment', 'type': 'DEVICE', 'otherNames': ['Urgent PC Neuromodulation System'], 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long', 'armGroupLabels': ['Active PTNS treatment']}, {'name': 'Sham treatment', 'type': 'DEVICE', 'otherNames': ['Simulated treatment'], 'description': 'One-week induction consisting of three active PTNS treatments, each 2 hours long', 'armGroupLabels': ['Sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospitals', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Kenneth Peters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman, Department of Urology', 'investigatorFullName': 'Kenneth M Peters, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}