Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-29 @ 8:54 AM
Study NCT ID:
NCT04488068
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transpelvic Magnetic Stimulation to Improve Urogenital Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mahadevan.Rajasekaran@VA.gov', 'phone': '8585528585', 'title': 'Mahadevan Rajasekaran, Ph.D.', 'phoneExt': '7114', 'organization': 'VA San Diego Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This is a feasibility study focused on recruitment and retention, and we did not focus on efficacy.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded throughout the 12-week treatment period.', 'description': 'Patients were asked to report any adverse effect using the Likert scale.', 'eventGroups': [{'id': 'EG000', 'title': 'Magnetic Stimulation', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison.\n\nAll patients were comfortable with the therapy and reported no adverse effects.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham TPMS', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS. No record of any adverse events as there were no patients in this arm.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Recruited', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Stimulation', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison.'}, {'id': 'OG001', 'title': 'Sham TPMS', 'description': 'Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 12-weeks therapy', 'description': 'Primary outcome measure will be to determine feasibility of recruitment of prostate cancer survivors. We will demonstrate recruitment in VASDHS urology clinics .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Prostate cancer survivors with UI and ED.'}, {'type': 'PRIMARY', 'title': 'Patient Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Stimulation', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison.'}, {'id': 'OG001', 'title': 'Sham TPMS', 'description': 'Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retention for 12 week study period.', 'description': 'Retention of these prostate cancer survivors for the study duration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Prostate cancer survivors with UI and ED.'}, {'type': 'PRIMARY', 'title': 'Patient Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Stimulation', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison.'}, {'id': 'OG001', 'title': 'Sham TPMS', 'description': 'Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks Post-therapy', 'description': 'Acceptability of TPMS treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Prostate cancer survivors with UI and ED.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Stimulation', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison. All 12 patients reported that the treatment is acceptable, painless,'}, {'id': 'OG001', 'title': 'Sham TPMS', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks post-therapy', 'description': 'The second objective is to test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. The investigators will use International Consultation of Incontinence Questionnaire (ICIQ)-symptom score, which assesses the symptoms and effect of UI on quality of life.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Prostate cancer survivors with UI and ED.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnetic Stimulation', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison. All 12 patients reported that the treatment is acceptable, painless,'}, {'id': 'OG001', 'title': 'Sham TPMS', 'description': 'Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks Post-therapy', 'description': 'The second objective is to test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. The investigators will evaluate The International Index of Erectile Function (IIEF) symptom scores to test the role of these changes in sexual function symptom severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Prostate cancer survivors with UI and ED.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnetic Stimulation', 'description': 'Patients will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison.'}, {'id': 'FG001', 'title': 'Sham TPMS', 'description': 'Patients will be subjected to sham TPMS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnetic Stimulation', 'description': 'Patients will be subjected to TPMS.\n\nSham Magnetic stimulation: Sham Magnetic stimulation for comparison. Despite the pandemic related restrictions during the initial study period, we managed to consent 12 and retain nine patients (age 55-75) for this feasibility study'}, {'id': 'BG001', 'title': 'Sham TPMS', 'description': 'No patients could be recruited for sham arm'}, {'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': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Out of the 12 patients consented, only 9 completed the 12-week treatment.'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '5', 'groupId': 'BG000'}, {'value': '65', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Information is collected using periodic personal interviews and questionnaires.', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The investigators measured symptoms of urine leakage and erectile dysfunction.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Out of 12 recruited patients, only 9 completed the 12-week treatment.'}, {'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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', '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': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patient recruitment', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Prostate cancer survivors with symptoms of urinary incontinence and erectile dysfunction'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-14', 'size': 317476, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-20T17:33', 'hasProtocol': True}, {'date': '2020-07-23', 'size': 265529, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-17T14:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention to prevent prostate cancer surgery related urological issues'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2020-06-29', 'resultsFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-30', 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Recruited', 'timeFrame': 'During 12-weeks therapy', 'description': 'Primary outcome measure will be to determine feasibility of recruitment of prostate cancer survivors. We will demonstrate recruitment in VASDHS urology clinics .'}, {'measure': 'Patient Retention', 'timeFrame': 'Retention for 12 week study period.', 'description': 'Retention of these prostate cancer survivors for the study duration.'}, {'measure': 'Patient Acceptability', 'timeFrame': '12 weeks Post-therapy', 'description': 'Acceptability of TPMS treatment'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome', 'timeFrame': '12 weeks post-therapy', 'description': 'The second objective is to test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. The investigators will use International Consultation of Incontinence Questionnaire (ICIQ)-symptom score, which assesses the symptoms and effect of UI on quality of life.'}, {'measure': 'Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome', 'timeFrame': '12 weeks Post-therapy', 'description': 'The second objective is to test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. The investigators will evaluate The International Index of Erectile Function (IIEF) symptom scores to test the role of these changes in sexual function symptom severity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urinary incontinence', 'hemodynamics'], 'conditions': ['Prostate Cancer', 'Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'After recruitment, 20 male patients will be assigned 1:1 to either age-matched control (G1: sham) or age-matched intervention (G2: pelvic magnetic stimulation; TPMS) groups using computer-generated process, and baseline parameters will be established. All patients will be instructed by the investigators to perform standard of care pelvic floor exercise for the duration of the study. In addition, G2 patients will receive TPMS, while G1 patients will undergo sham treatment.', 'detailedDescription': 'The investigators will use a custom TPMS device that targets pelvic muscles. The investigators will apply low amplitude (5%) TPMS to improve blood flow, then high amplitude (30-50%) to strengthen pelvic muscles. The treatment regimen will involve two 20-minute sessions/visit and 2 -visits per week for 12-weeks (final monitoring at 24 weeks). TPMS will be administered by a trained clinical coordinator under the supervision of a urologist. Symptom scores and hemodynamic changes will be evaluated monthly. MRI for assessing muscle thickness will be performed in the beginning (before TPMS) and at the end (after TPMS) of the study. The investigators will assess functional improvements using symptom scores. Morphological changes will be determined by MRI.\n\nThe secondary outcome measures: Change in number of pads used as a measure of Improvements in continence function, Improvements in penile blood flow change, Improvements in pelvic muscle thickness change, Change in Pad weight as a measure of Improvements in continence function; were changed/replaced by secondary outcome measures that clearly align with the proposed aims of the study as follows: 1) To show the feasibility of recruitment of prostate cancer survivors, acceptability of Transpelvic magnetic Stimulation (TPMS) intervention, and retention of this Veteran population, we will demonstrate recruitment in VA SAN DIEGO HEALTH CARE SYSTEM (VASDHS) urology clinics and retention of these patients for the study duration. 2) To test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. 3) To test the feasibility of diagnostic imaging to establish: penile/ pelvic floor muscle (PFM) blood flow, PFM anatomical and morphological changes before surgery, immediately after surgery, and after TPMS interventions.\n\nThe third aim of the study was not feasible as the study was performed during the pandemic. Therefore, the outcome measures: Improvements in penile blood flow change and Improvements in pelvic muscle thickness change were removed. The secondary outcome measures were to test the feasibility of administering symptom scores in this population of prostate cancer survivors (not efficacy). Therefore, the outcome measures: Change in number of pads used as a measure of Improvements in continence function and Change in Pad weight as a measure of Improvements in continence function were removed. The secondary outcome measures were changed to the current outcome measures: Number of Patients that completed The International Consultation on Incontinence Questionnaire (ICIQ) scores (as a measure of urinary incontinence; UI ) and Number of Patients that completed The International Index of Erectile Function (IIEF; as a measure of erectile dysfunction; ED) scores as these measures directly align with our study aims. Final monitoring at 24 weeks also was not feasible, so the outcome measure time frame was 12 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men over 50 years old who are enrolled for prostate surgery,\n* have serum testosterone within normal limits, and\n* are without prior bilateral orchiectomy, chemotherapy, external radiotherapy, brachytherapy, surgical, or other ablative therapy for prostate cancer.\n\nExclusion Criteria:\n\n* patients with ED caused by psychological, neurogenic (after non-nerve sparing prostate surgery), or hormonal disorders,\n* patients with genital abnormalities precluding intercourse, prior penile implantation, ongoing erectile aid use, or use of nitrate medications.\n* Androgen suppression within the past 6 months or as part of protocol-specified radiotherapy or brachytherapy will be excluded.'}, 'identificationModule': {'nctId': 'NCT04488068', 'briefTitle': 'Transpelvic Magnetic Stimulation to Improve Urogenital Function', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors', 'orgStudyIdInfo': {'id': 'F3455-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnetic Stimulation', 'description': 'Patients will be subjected to TPMS.', 'interventionNames': ['Procedure: Sham Magnetic stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Sham TPMS', 'description': 'Patients will be subjected to sham TPMS'}], 'interventions': [{'name': 'Sham Magnetic stimulation', 'type': 'PROCEDURE', 'description': 'Sham Magnetic stimulation for comparison.', 'armGroupLabels': ['Magnetic Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Mahadevan R. Rajasekaran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System, San Diego, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}