Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT04066894
Status:
TERMINATED
Last Update Posted:
2023-08-14
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094123', 'term': 'Low Anterior Resection Syndrome'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010386', 'term': 'Pelvic Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020878', 'term': 'Device Removal'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cmessick@mdanderson.org', 'phone': '(713) 745-1544', 'title': 'Dr. Craig Messick', 'organization': 'M D Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From visit 1, up to 3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sacral Nerve Stimulation (SNS) Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to visit 3', 'description': 'SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Fecal Incontinence Severity Index Questionnaire Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Fecal Incontinence Quality of Life Questionnaire Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Low Anterior Resection Syndrome Score BFQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Cleveland Clinic Incontinence Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Impact of SNS on Bowel Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 30 days (visit 2)', 'description': 'Will be measured using bowel diaries.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Impact of SNS on Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 30 days (visit 2)', 'description': 'Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Sacral Nerve Stimulation (SNS)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-20', 'size': 971056, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-29T17:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Due to Issues Enrolling Patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2019-06-11', 'resultsFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-20', 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sacral Nerve Stimulation (SNS) Success', 'timeFrame': 'Up to visit 3', 'description': 'SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)'}], 'secondaryOutcomes': [{'measure': 'Fecal Incontinence Severity Index Questionnaire Summary', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}, {'measure': 'Fecal Incontinence Quality of Life Questionnaire Summary', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}, {'measure': 'Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}, {'measure': 'International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}, {'measure': 'Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}, {'measure': 'Low Anterior Resection Syndrome Score BFQ', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}, {'measure': 'Cleveland Clinic Incontinence Score', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}, {'measure': 'Impact of SNS on Bowel Dysfunction', 'timeFrame': 'Up to 30 days (visit 2)', 'description': 'Will be measured using bowel diaries.'}, {'measure': 'Impact of SNS on Urinary Incontinence', 'timeFrame': 'Up to 30 days (visit 2)', 'description': 'Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.'}, {'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29', 'timeFrame': 'Up to 3 years', 'description': 'Will be reported descriptively with graphs or tabulations for categorical survey outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Low Anterior Resection Syndrome', 'Malignant Anal Neoplasm', 'Malignant Bladder Neoplasm', 'Malignant Cervical Neoplasm', 'Malignant Ovarian Neoplasm', 'Malignant Pelvic Neoplasm', 'Malignant Prostate Neoplasm', 'Malignant Uterine Neoplasm', 'Malignant Vaginal Neoplasm', 'Malignant Vulvar Neoplasm', 'Rectal Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': "This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To investigate the efficacy of sacral nerve stimulator placement in patients with fecal incontinence (FI) or low anterior resection syndrome (LARS) who have previously undergone chemoradiation treatment (XRT) and/or a restorative partial or complete proctectomy with colorectal or coloanal anastomosis for cancer treatment as per standard of care (restorative surgery cohort).\n\nII. To evaluate the feasibility of sacral nerve stimulator placement in patients with fecal incontinence (FI) or other defecatory dysfunction who have received pelvic radiation treatment without undergoing rectal or other pelvic surgery as per standard of cancer care (radiation only cohort).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the effectiveness of sacral nerve stimulation (SNS) as measured by validated questionnaires in patients with FI or LARS within both patient cohorts.\n\nII. To evaluate pelvic floor and sphincter physiology using anorectal manometry (ARM) before and after SNS in patients with FI or LARS within both patient cohorts.\n\nIII. To assess potential impact of SNS on urinary incontinence measuring a post-void urinary bladder residual and validated urinary symptom questionnaires in both patient cohorts.\n\nIV. To assess efficacy of SNS on long-term bowel dysfunction at 1 and 3 years post battery implantation as measured by validated questionnaires for both patient cohorts.\n\nOUTLINE:\n\nPatients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.\n\nAfter completion of study, patients are followed up at 1 month, 1 year, and 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer\n* Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation\n* Cohort 1: Patients treated with restorative surgical resection without radiation\n* Cohort 1: Patients with any T-stage or N-stage rectal cancer that underwent treatment with radiation and restorative surgery\n* Cohort 1: Patients with self-reported FI or LARS\n* Cohort 1: Patients must be at least 18 years old and be able to speak and understand English\n* Cohort 1: Patients must be willing to and able to sign an approved informed consent document\n* Cohort 1: Patients must be \\>= 24 months post-resection of rectal cancer\n* Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion\n* Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery\n* Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function\n* Cohort 1: Patients who have an average resting tone \\< 40 mmHg (normal \\> 40 mmHg) and maximal tolerance \\< 200 milliliters (normal 200-300 milliliters) as measured by ARM\n* Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary)\n* Cohort 2: Patients treated with standard of care radiation therapies without surgical resection\n* Cohort 2: Patients with self-reported FI or other defecatory dysfunction\n* Cohort 2: Patients must be at least 18 years old and be able to speak and understand English\n* Cohort 2: Patients must be willing to and able to sign an approved informed consent document\n* Cohort 2: Patients must be \\>= 18 months post-pelvic chemoradiation\n* Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction\n* Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study\n* Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function\n* Cohort 2: Patients who have an average resting tone \\< 40 mmHg (normal \\> 40 mmHg) and maximal tolerance \\< 200 milliliters (normal 200-300 milliliters) as measured by ARM\n\nExclusion Criteria:\n\n* Cohort 1: Patients with co-morbid illnesses or concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Cohort 1: Any diverting bowel ostomy at the time of consent to this study\n* Cohort 1: Patients with an absolute neutrophil count (ANC) \\< 1.7 within 30 days of consent\n* Cohort 1: Patients with an international normalized rate (INR) \\> 1.3 within 30 days of consent\n* Cohort 1: Patients with a platelet count \\< 50 K within 30 days of consent\n* Cohort 1: Patients currently being treated with chemotherapy or within preceding 30 days at the time consent\n* Cohort 1: Patients previously treated with a SNS for urinary or FI\n* Cohort 1: Patients who were documented to have an anastomotic leak following their restorative surgical resection\n* Cohort 1: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status \\> 2 at the time of consent\n* Cohort 1: Patients with an active infection requiring systemic therapy at the time of consent\n* Cohort 1: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure\n* Cohort 2: Co-morbid illnesses or other concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Cohort 2: Patients with an ANC \\< 1.7 within 30 days of consent\n* Cohort 2: Patients with an INR \\> 1.3 within 30 days of consent\n* Cohort 2: Patients with a platelet count \\< 50 K, within 30 days of consent\n* Cohort 2: Patients currently being treated with chemotherapy or within the preceding 30 days at the time of consent\n* Cohort 2: Patients previously treated with a sacral nerve stimulator for urinary or fecal incontinence\n* Cohort 2: Patients with an ECOG performance status \\> 2 at the time of consent\n* Cohort 2: Patients with an active infection requiring systemic therapy at the time of consent\n* Cohort 2: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure\n* Cohort 2: Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study"}, 'identificationModule': {'nctId': 'NCT04066894', 'briefTitle': 'Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Phase II Study of Sacral Nerve Stimulation for Low Anterior Resection Syndrome or Fecal Incontinence in Patients Following a Low Anterior Resection or Proctectomy With Coloanal Anastomosis or in Patients After Pelvic Chemoradiation (RESTORE)', 'orgStudyIdInfo': {'id': '2016-0754'}, 'secondaryIdInfos': [{'id': 'NCI-2019-02649', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2016-0754', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Care (sacral nerve stimulator)', 'description': 'Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.', 'interventionNames': ['Procedure: Explantation', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Device: Sacral Nerve Stimulator', 'Device: Sacral Nerve Stimulator Battery', 'Procedure: Therapeutic Conventional Surgery']}], 'interventions': [{'name': 'Explantation', 'type': 'PROCEDURE', 'description': 'Undergo lead removal', 'armGroupLabels': ['Supportive Care (sacral nerve stimulator)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (sacral nerve stimulator)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (sacral nerve stimulator)']}, {'name': 'Sacral Nerve Stimulator', 'type': 'DEVICE', 'otherNames': ['Sacral Neuromodulator'], 'description': 'Undergo sacral nerve stimulator implantation', 'armGroupLabels': ['Supportive Care (sacral nerve stimulator)']}, {'name': 'Sacral Nerve Stimulator Battery', 'type': 'DEVICE', 'otherNames': ['Sacral Neuromodulator Battery'], 'description': 'Undergo sacral nerve stimulator battery implantation', 'armGroupLabels': ['Supportive Care (sacral nerve stimulator)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo sacral nerve stimulator implantation', 'armGroupLabels': ['Supportive Care (sacral nerve stimulator)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson in Sugar Land', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}], 'overallOfficials': [{'name': 'Craig A Messick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}