Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-26 @ 1:48 PM
Study NCT ID:
NCT07171567
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of recruitment to study', 'timeFrame': '6 months', 'description': 'To evaluate the feasibility of recruitment to a study examining the daily use of vacuum erection device (VED) therapy over a 6-month period in adult males with penile numbness or reduced sensation. Feasibility will be assessed via the ability to enroll subjects within a 1 year period and by treatment adherence and completion rates. Treatment adherence/completion will be assessed during standardized study visits'}, {'measure': 'Acceptability of treatment', 'timeFrame': '6 months', 'description': 'Acceptability will be evaluated through patient-reported experiences using online questionnaires. Changes in penile sensation will be measured using patient-reported outcomes of erectile function (standardized questionnaires) and a subjective Likert scale of penile numbness collected at baseline, throughout the study and at the end of the 6-month intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Penile numbness', 'Penile sensation changes'], 'conditions': ['Penile Numbness']}, 'descriptionModule': {'briefSummary': "This is a prospective, uncontrolled, Hypothesis generating study. A total of eight adult male participants experiencing penile insensitivity will be recruited through the Ottawa Hospital's Men's Health Clinic. Participants will receive a Health Canada Class I VED to use daily over a six-month period. The study includes biweekly check-ins and monthly questionnaire assessments (including the IIEF-5 and two custom instruments focused on penile sensitivity) administered via Lime Survey.\n\nThe primary outcome is to explore the feasibility and acceptability of daily vacuum erection device (VED) therapy over a 6-month period in adult males experiencing penile numbness/insensitivity. Data analysis will focus on feasibility metrics (e.g., adherence rates, completion of assessments) and descriptive statistics. Any changes in questionnaire scores over time will be evaluated using within-subject comparisons (e.g., Wilcoxon signed-rank test), recognizing that findings are preliminary and not generalizable due to the lack of a control group."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male adults (age 18 and over)\n* Have been seen by a urologist in consultation for penile numbness/insensitivity\n\n5.2 Exclusion Criteria\n\n\\- Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT07171567', 'briefTitle': 'Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Vacuum Therapy for the Treatment of Penile Numbness/Sensory Changes', 'orgStudyIdInfo': {'id': '20250231-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vacuum erection device (VED)', 'interventionNames': ['Device: Vacuum erection device']}], 'interventions': [{'name': 'Vacuum erection device', 'type': 'DEVICE', 'description': 'A vacuum erection device (VED) is a mechanical device designed to enhance blood flow to the corpora cavernosa by creating a vacuum environment. When combined with a constriction ring at the base of the penis, VEDs can promote and sustain an erection.\n\nThis is a prospective, uncontrolled, hypothesis-generating pilot study. Eight adult male participants with penile insensitivity will be enrolled and asked to use a VED daily for six months. Monthly self-reported questionnaire data and biweekly follow-up calls will be used to assess feasibility and to collect exploratory outcome data.', 'armGroupLabels': ['vacuum erection device (VED)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y4E9', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Amanda Ross', 'role': 'CONTACT', 'email': 'amanross@toh.ca', 'phone': '6137985555'}, {'name': 'Luke Witherspoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Luke Witherspoon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}