Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-29 @ 4:57 AM
Study NCT ID:
NCT06275256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of MIST for BPH: A Single-Institution Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Scores', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Using the IPSS (International Prostate Symptom Score) questionnaires to measure improvement in symptom scores'}, {'measure': 'Uroflow', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Measuring uroflow parameters such as Qmax pre and post procedure'}, {'measure': 'Uroflow', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Measuring uroflow parameters such as PVR (post-void residual volume) pre and post procedure'}, {'measure': 'Symptom Scores', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Using the MHSQ-EjD (Male Sexual Health Questionnaire) questionnaire to measure changes in symptom scores'}, {'measure': 'Symptom Scores', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Using the IIEF-15 (Index of Erectile Function) questionnaire to measure changes in symptom scores'}, {'measure': 'Symptom Scores', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Using the OAB-qSF (overactive bladder symptom and health-related quality of life short-form questionnaire) to measure changes in symptom scores'}], 'secondaryOutcomes': [{'measure': 'Pain Scale', 'timeFrame': '1, 3, 6 months post-procedure', 'description': 'Using a visual analogue pain scale \\[range 0-10; 0 = no pain, 10 = maximal pain\\], pain will be assessed as reported by the patient post-operatively to determine their pain'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': "The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile.", 'detailedDescription': "This prospective study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients who are to undergo Rezum or iTind procedure for BPH/LUTS between March 2024 and March 2025 are to be included in the study. Patient meeting inclusion criteria and exclusion criteria will be recruited to participate in this study.\n\nInclusion criteria: patients \\> 18 years of age, undergoing Rezum or iTind treatment Exclusion criteria: ASA III or higher, active UTI within past week, age \\< 18 years of age, no informed consent Follow-up/data measurements will occur pre-procedure, immediately post procedure, 1 week, 6 weeks, and 3 months following procedure. At time of consultation pre-procedure, baseline symptom scores, uroflow parameters will be obtained. VAS pain score is to be obtained during procedure, immediately post procedure, and at time of catheter or device removal 1 week post procedure. Uroflow parameters and symptoms scores will be again measured at 6 weeks and 3 months."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\> 18 years of age undergoing Rezum or iTind treatment\n\nExclusion Criteria:\n\n* ASA 3 or higher, active UTI within past week, age \\< 18 years of age, no informed consent'}, 'identificationModule': {'nctId': 'NCT06275256', 'briefTitle': 'Outcomes of MIST for BPH: A Single-Institution Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Outcomes of Minimally Invasive Surgical Treatments (MIST) for Benign Prostatic Hyperplasia (BPH): A Single-Institution Prospective Study', 'orgStudyIdInfo': {'id': 'HS26226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rezum', 'description': 'This arm will receive the Rezum procedure.', 'interventionNames': ['Procedure: Rezum']}, {'type': 'EXPERIMENTAL', 'label': 'iTind', 'description': 'This arm will receive the iTind Procedure', 'interventionNames': ['Device: iTind']}], 'interventions': [{'name': 'Rezum', 'type': 'PROCEDURE', 'description': "The Rezum device is inserted, a needle is deployed, and vapor is injected into the prostate for nine seconds. This vapor disperses between cells, then cools, releases heat, and gently disrupts the prostate's cells. Because of the initial swelling, a catheter is then inserted, which will remain for two to five days.", 'armGroupLabels': ['Rezum']}, {'name': 'iTind', 'type': 'DEVICE', 'description': 'The iTind device is temporarily placed inside the prostatic urethra (the narrowed portion of the prostate), where it slowly expands and exerts gentle pressure at three precise points. The effect of the iTind is to widen the prostatic urethral opening through which urine can now flow more easily.', 'armGroupLabels': ['iTind']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3K 1M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'contacts': [{'name': 'Premal Patel, MD', 'role': 'CONTACT', 'email': 'ppatel5@hsc.mb.ca', 'phone': '204-221-4476'}, {'name': 'Harliv Dhillon, BSc', 'role': 'CONTACT', 'email': 'harlivmhc@gmail.com', 'phone': '2049904153'}], 'facility': "Men's Health Clinic", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Premal Patel, MD', 'role': 'CONTACT', 'email': 'ppatel5@hsc.mb.ca', 'phone': '204-221-4476'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education', 'investigatorFullName': 'Premal Patel, MD', 'investigatorAffiliation': 'University of Manitoba'}}}}