Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-24 @ 10:29 PM
Study NCT ID:
NCT03083366
Status:
TERMINATED
Last Update Posted:
2025-06-10
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karena.mcdonald@hsc.utah.edu', 'phone': '801-699-9740', 'title': 'Karena McDonald', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Target enrollment was not met and the study was terminated early. Due to the small number of subjects enrolled, there was insufficient data to achieve target power and statistically reliable results. Also, data were not collected for all participants at all study timepoints resulting in an incomplete dataset and uninterpretable data.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to end of follow-up period at 12 months', 'description': 'Adverse events were collected via participant query, questionnaire, and laboratory testing.', 'eventGroups': [{'id': 'EG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Cystometric Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '400', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Maximum bladder capacity as measured by urodynamic study at 12 months', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study. Data only collected for one participant in the sacral neuromodulation group at 12 months because the other did not return for their 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.'}, {'type': 'PRIMARY', 'title': 'Quality of Life Differences Measured by Mean SCI-QoL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'spread': '0', 'groupId': 'OG000'}, {'value': '180', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Participant-reported quality of life as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) bladder question banks at 12 months. Scores range from 64-320 with a lower score indicating greater satisfaction with quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study. Data only collected for one participant in the sacral neuromodulation group at 12 months because the other did not complete their 12 month questionnaires.'}, {'type': 'PRIMARY', 'title': 'Number of Urinary Tract Infections Requiring Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from enrollment through the end of follow-up at 12 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Maximum Cystometric Capacity at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '650', 'spread': '0', 'groupId': 'OG000'}, {'value': '231', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Maximum bladder capacity as measured by urodynamic study at 3 months', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Data only collected for one participant in the sacral neuromodulation group at 3 months because the other did not return for their 3 month UDS.'}, {'type': 'SECONDARY', 'title': 'Bladder Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '0', 'groupId': 'OG000'}, {'value': '12.16', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data collected was determined to be invalid due to grossly out of range value.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 12 months', 'description': 'Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.', 'unitOfMeasure': 'mL/cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Data only collected for one participant in the sacral neuromodulation group at 3 \\& 12 months because the other did not return for their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.'}, {'type': 'SECONDARY', 'title': 'Presence of Detrusor Overactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3, 12 months', 'description': 'Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Data only collected for one participant in the sacral neuromodulation group at 3 \\& 12 months because the other did not return for their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.'}, {'type': 'SECONDARY', 'title': 'Volume at First Detrusor Contraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 12 months', 'description': 'Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Data not collected for the sacral neuromodulation group at 3 \\& 12 months because one participant did not return for their 3 or 12 month UDS and this specific data point was inadvertently not recorded for the other participant during their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.'}, {'type': 'SECONDARY', 'title': 'Pressure at First Detrusor Contraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 12 months', 'description': 'Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Data not collected for the sacral neuromodulation group at 3 \\& 12 months because one participant did not return for their 3 or 12 month UDS and this specific data point was inadvertently not recorded for the other participant during their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.'}, {'type': 'SECONDARY', 'title': 'Daily Number of Catheterizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '0', 'groupId': 'OG000'}, {'value': '2', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.67', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6, 9, 12 months', 'description': 'Daily number of catheterizations as reported in the participant diary.', 'unitOfMeasure': 'catheterizations per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 6 or 12 months.'}, {'type': 'SECONDARY', 'title': 'Average Catheterization Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '358.33', 'spread': '0', 'groupId': 'OG000'}, {'value': '461.67', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '400', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '472.22', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.42', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6, 9, 12 months', 'description': 'Average catheterization volume as determined by participant diary.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 6 or 12 months.'}, {'type': 'SECONDARY', 'title': 'Urinary Incontinence Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6, 9, 12 months', 'description': 'Urinary incontinence episodes per day as determined by participant diary.', 'unitOfMeasure': 'incontinence episodes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 3, 6, or 12 months.'}, {'type': 'SECONDARY', 'title': '24 Hour Pad Weight Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 6, 9, 12 months', 'description': '24 hour pad weight as determined by participant diary.', 'unitOfMeasure': 'oz', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 6, 9, or 12 months.'}, {'type': 'SECONDARY', 'title': 'Development of Hydronephrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'timeFrame': '12 months', 'description': 'Development of hydronephrosis during the study period as determined by ultrasound at 12 months.', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the study. Data not collected for either group because participants in both groups did not return for their 12 month ultrasound.'}, {'type': 'SECONDARY', 'title': 'Need for Anticholinergic Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from enrollment through the end of follow-up at 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants. Data not reported for one of the participants in the sacral neuromodulation group.'}, {'type': 'SECONDARY', 'title': 'Need for Onabotulinum Toxin A Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from enrollment through the end of follow-up at 12 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants. Data not reported for one of the participants in the sacral neuromodulation group.'}, {'type': 'SECONDARY', 'title': 'Need for Device Revision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from implant through the end of follow-up at 12 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had the device implanted were included.'}, {'type': 'SECONDARY', 'title': 'Device Explanation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from implant through the end of follow-up at 12 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had device implanted were included.'}, {'type': 'SECONDARY', 'title': 'Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from enrollment through the end of follow-up at 12 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were included.'}, {'type': 'SECONDARY', 'title': 'Urologic Related Surgeries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from enrollment through the end of follow-up at 12 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were included.'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from enrollment through the end of follow-up at 12 months', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'periods': [{'title': 'Screening Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not meet criteria (screen fail)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Enrollment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study recruited participants from March 2019 to May 2022, with the first patient enrolled in August 2019. Patients were recruited from participating sites as well as online advertising.', 'preAssignmentDetails': 'There was a screening phase in order to identify eligible participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sacral Neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.\n\nPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'Patients will receive standard neurogenic bladder care.'}, {'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': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', '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': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', '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': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-21', 'size': 186943, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-09T11:59', 'hasProtocol': True}, {'date': '2021-04-28', 'size': 368941, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-12T16:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized non-blinded study of sacral neuromodulation plus standard neurogenic bladder care versus standard neurogenic bladder care in patients with spinal cord injury'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'The study was unable to meet enrollment goals', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2017-01-27', 'resultsFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-09', 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Cystometric Capacity', 'timeFrame': '12 months', 'description': 'Maximum bladder capacity as measured by urodynamic study at 12 months'}, {'measure': 'Quality of Life Differences Measured by Mean SCI-QoL', 'timeFrame': '12 months', 'description': 'Participant-reported quality of life as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) bladder question banks at 12 months. Scores range from 64-320 with a lower score indicating greater satisfaction with quality of life.'}, {'measure': 'Number of Urinary Tract Infections Requiring Antibiotics', 'timeFrame': 'from enrollment through the end of follow-up at 12 months'}], 'secondaryOutcomes': [{'measure': 'Maximum Cystometric Capacity at 3 Months', 'timeFrame': '3 months', 'description': 'Maximum bladder capacity as measured by urodynamic study at 3 months'}, {'measure': 'Bladder Compliance', 'timeFrame': '3, 12 months', 'description': 'Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.'}, {'measure': 'Presence of Detrusor Overactivity', 'timeFrame': '3, 12 months', 'description': 'Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.'}, {'measure': 'Volume at First Detrusor Contraction', 'timeFrame': '3, 12 months', 'description': 'Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.'}, {'measure': 'Pressure at First Detrusor Contraction', 'timeFrame': '3, 12 months', 'description': 'Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.'}, {'measure': 'Daily Number of Catheterizations', 'timeFrame': '3, 6, 9, 12 months', 'description': 'Daily number of catheterizations as reported in the participant diary.'}, {'measure': 'Average Catheterization Volume', 'timeFrame': '3, 6, 9, 12 months', 'description': 'Average catheterization volume as determined by participant diary.'}, {'measure': 'Urinary Incontinence Episodes Per Day', 'timeFrame': '3, 6, 9, 12 months', 'description': 'Urinary incontinence episodes per day as determined by participant diary.'}, {'measure': '24 Hour Pad Weight Test', 'timeFrame': '3, 6, 9, 12 months', 'description': '24 hour pad weight as determined by participant diary.'}, {'measure': 'Development of Hydronephrosis', 'timeFrame': '12 months', 'description': 'Development of hydronephrosis during the study period as determined by ultrasound at 12 months.'}, {'measure': 'Need for Anticholinergic Medication', 'timeFrame': 'from enrollment through the end of follow-up at 12 months'}, {'measure': 'Need for Onabotulinum Toxin A Injection', 'timeFrame': 'from enrollment through the end of follow-up at 12 months'}, {'measure': 'Need for Device Revision', 'timeFrame': 'from implant through the end of follow-up at 12 months'}, {'measure': 'Device Explanation', 'timeFrame': 'from implant through the end of follow-up at 12 months'}, {'measure': 'Hospitalizations', 'timeFrame': 'from enrollment through the end of follow-up at 12 months'}, {'measure': 'Urologic Related Surgeries', 'timeFrame': 'from enrollment through the end of follow-up at 12 months'}, {'measure': 'Death', 'timeFrame': 'from enrollment through the end of follow-up at 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['spinal cord injury', 'Neurogenic', 'bladder', 'electrical stimulation', 'neuromodulation'], 'conditions': ['Spinal Cord Injury, Acute', 'Neurogenic Bladder', 'Incontinence', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '30157824', 'type': 'DERIVED', 'citation': 'Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, Rosenbluth JP, Presson AP, Myers JB; Neurogenic Bladder Research Group (NBRG.org). Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury. BMC Urol. 2018 Aug 29;18(1):72. doi: 10.1186/s12894-018-0383-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. Within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. Patients will be assigned to one of these groups at random and followed for one year. The hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Ability to implant device less than 12 weeks post-spinal cord injury (SCI)\n* Presence of acute SCI at or above T12\n* American Spinal Injury Association (ASIA) Scale A or B\n* Expectation to perform clean intermittent catheterization (CIC) personally or have caretaker perform CIC\n\nExclusion Criteria:\n\n* Inability to perform CIC\n* Pre-existing SCI\n* Pre-existing progressive neurological disorder\n* Autonomic dysreflexia\n* Prior sacral back surgery\n* Posterior pelvic fracture with distortion of the sacroiliac joint\n* Prior urethral sphincter or bladder dysfunction\n* Chronic urinary tract infections prior to SCI\n* Pregnancy at the time of enrollment\n* Presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure\n* Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure\n* Active untreated infection\n* Traumatic injury to the genitourinary system\n* Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology'}, 'identificationModule': {'nctId': 'NCT03083366', 'briefTitle': 'Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury', 'orgStudyIdInfo': {'id': '96153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sacral neuromodulation', 'description': 'Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.', 'interventionNames': ['Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Patients will receive standard neurogenic bladder care.'}], 'interventions': [{'name': 'PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)', 'type': 'DEVICE', 'otherNames': ['Sacral neuromodulation'], 'description': 'Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)', 'armGroupLabels': ['Sacral neuromodulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Los Amigos National Rehabilitation Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Jeremy B Myers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rancho Research Institute, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Jeremy Myers', 'investigatorAffiliation': 'University of Utah'}}}}