Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06803602
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2025-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)', 'timeFrame': 'Baseline, 6 weeks, 15 weeks', 'description': 'The International Consultation on Incontinence Questionnaire (ICIQ-SF) is a 4-item questionnaire that assesses the frequency, amount, and impact of urinary leakage. The ICIQ-SF has a scoring range of 0-21, with higher scores indicating more severe symptoms.'}, {'measure': 'Pad weight test', 'timeFrame': 'Baseline, 6 weeks, 15 weeks', 'description': 'For the pad weight test, subjects will be provided with a small scale and asked to measure the weight of their pad before and after wearing for 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Change in International Prostate Symptom Score (IPSS)', 'timeFrame': 'Baseline, 6 weeks, 15 weeks', 'description': 'The International Prostate Symptom Score (IPSS) is a 7-item questionnaire used to assess urinary symptoms, such as incomplete emptying, frequency, urgency, and weak stream. Each question has six possible answers, ranging from 0 to 5 points, with higher numbers indicating more severe symptoms.'}, {'measure': 'Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF)', 'timeFrame': 'Baseline, 6 weeks, 15 weeks', 'description': 'The Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF) is a 4 item questionnaire to assess the degree of ejaculatory dysfunction in men. The domains include three ejaculatory function items and one ejaculation bother item.'}, {'measure': 'Change in Quality of Life Scale', 'timeFrame': 'Baseline, 6 weeks, 15 weeks', 'description': 'The Quality of Life Scale is a 16-item instrument that measures six domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, recreation, and independence on a scale of 1 to 7 where a low value indicates "terrible" and a high value indicates "delighted". Higher overall scores indicate better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Holmium Laser Prostate Surgery', 'Radical Prostatectomy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of High-Intensity Focused Electromagnetic (HIFEM) technology in improving the recovery time of urinary control and quality of life for male patients after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are male\n* Post-radical prostatectomy or post HoLEP\n* Experiencing urinary incontinence one-month post-RP\n* Have the capacity to make their own medical decisions\n* Able to complete the questionnaires and visits required.\n\nExclusion Criteria:\n\n* Subjects who are not male\n* Not post-radical prostatectomy or post HoLEP\n* Neurologic disease\n* Atonic or hypofunctional bladder (bladder contractility index (BCI) \\< 100; BCI = pDetQmax+5Qmax)\n* Status post pelvic radiation\n* Past surgical history of other GU surgeries\n* Gross hematuria\n* Concomitant use of medications that cause muscle relaxation or inhibition\n* Indwelling foley catheter at time of treatment\n* Documented urine leak\n* Not experiencing urinary incontinence\n* Do not have the capacity to make their own medical decisions\n* Unable to complete the questionnaires provided.'}, 'identificationModule': {'nctId': 'NCT06803602', 'briefTitle': 'HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluating the Efficacy of High-Intensity Focused Electromagnetic Technology in Improving the Time of Recovery of Urinary Control of Continence and Quality of Life for Post-Surgical Patients', 'orgStudyIdInfo': {'id': '24-010450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Subjects randomized to the treatment group will receive 2, 30-minute sessions, weekly for 3 weeks using the Emsella device.\n\nAfter a 1 week wash-out period, subjects still experiencing urinary leakage will have the option to continue treatment for 3 additional weeks.', 'interventionNames': ['Device: EMSELLA®']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects randomized to the placebo group will receive 2, 30-minute sessions, weekly for 3 weeks using a sham comparator device.\n\nAfter a 1 week wash-out period, subjects in the placebo group who are experiencing urinary leakage will be offered the opportunity to cross-over to an active treatment group for an additional 3 weeks.', 'interventionNames': ['Device: Sham Comparator Device']}], 'interventions': [{'name': 'EMSELLA®', 'type': 'DEVICE', 'description': 'Subjects will receive 100% intensity of the EMSELLA® (BTL Industries, Marlborough, MA) High-Intensity Focused Electromagnetic (HIFEM) treatment, in a single 30-minute session, twice per week for 3 weeks.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Sham Comparator Device', 'type': 'DEVICE', 'description': 'Subjects will be asked to sit on the EMSELLA® (BTL Industries, Marlborough, MA) treatment head which will be powered off and instead have a small remote control vibration device that will simulate active treatment, in a single 30-minute session, twice per week for 3 weeks.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Mitchell R Humphreys, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mitchell Humphreys', 'investigatorAffiliation': 'Mayo Clinic'}}}}