Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT00277095
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2006-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'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': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'sshriram@uromedica-inc.com', 'phone': '763-694-9880', 'title': 'Sabitha R Shriram', 'phoneExt': '216', 'organization': 'Uromedica'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 Months', 'eventGroups': [{'id': 'EG000', 'title': 'ProACT', 'description': 'Implantable device', 'otherNumAtRisk': 124, 'otherNumAffected': 112, 'seriousNumAtRisk': 124, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Other Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 79, 'numAffected': 46}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Other Non Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 54, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Pain Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 47, 'numAffected': 35}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Worsening Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Balloon Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 30, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Infection, Urinary Tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Perforation During Implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Dermotologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Gastrointestinal Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Oncological/hematologic Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Device Failure, Leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Infection, Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Balloon Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Pain, nongenitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Cardiac Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Device Failure, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}], 'seriousEvents': [{'term': 'CVA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Low Heart Rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Ulcerative Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICH GCP April 1996'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Urine Loss ( in Grams)', 'description': '24 hour pad weight(in grams) demonstrating 50% reduction in urine loss (in grams)over 18th month'}], 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 month follow-up', 'description': 'The percentage of participants with 50% reduction in pad weight.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As followed analysis of all patients who were treated and reached the 18 month follow-up visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implantable Device', 'description': 'ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Anatomy of 1 patient did not allow ProACT to be implanted, hence only 123 patients were implanted.', 'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Details of patients who did not complete study are given below.', 'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Explanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Missed Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ProACT', 'description': 'Implantable device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2006-01-11', 'resultsFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2006-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.', 'timeFrame': '18 month follow-up', 'description': 'The percentage of participants with 50% reduction in pad weight.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary Incontinence'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=3425', 'label': 'ProACT Adjustable Continence for Men Premarket Approval (PMA) 11/24/2015'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.\n\nThe results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.', 'detailedDescription': 'The study is a prospective, non-randomized multi-center investigation. Multiple measurements using 24 hour pad weight and pad count, validated questionnaires, voiding diaries will be used to evaluate the achievement of the study objectives. Subjects will be followed for a minimum of 18 months following implantation. Subjects will be requested to continue annual follow-ups through the FDA approval.\n\nThe purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.\n\nThe results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergone either a radical prostatectomy, transurethral resection of the prostate or other prostate surgery at least 12 months prior without radiation therapy\n* Demonstrate primary stress urinary incontinence\n* Male subjects at least 45 years of age\n* Willing and able to undergo surgical implantation of the ProACT devices\n* Willing and able to comply with the follow-up requirements\n* Willing and able to forego any other surgical urinary incontinence treatments while participating in the study\n* Willing and able to sign the informed consent\n* Positive 24 hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests)\n* Experiences at least 3 incontinence episodes per day during two baseline voiding diaries.\n* Negative Urine culture\n* No recurrent stricture at the anastamosis\n* No known urogenital malignancy other than previously treated prostate cancer\n* Physician determines subject to be suitable surgical candidate\n\nExclusion Criteria:\n\n* Primarily Urge incontinence\n* Detrusor instability or over-activity\n* Residual volume greater that 100 ml or greater than 25% of the total bladder capacity after voiding.\n* Subject has/had or is suspected of having bladder cancer\n* History of recurrent bladder stones\n* Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia\n* Known hemophilia or a bleeding disorder\n* Abnormal PSA (Prostate Specific Antigen), according to sites laboratory standards, unless further investigation confirms no underlying prostate malignancy.\n* Known sever contrast solution allergy\n* Has a genitourinary mechanical prosthesis other than previous sling procedure (e.g., Artificial Urinary sphincter, implantable penile prosthesis)\n* Has a urethral stricture that prevents passage of an 18 F cystoscope or has had more than one urethrotomy\n* Undergone bulking procedure within 6 months of the baseline assessment\n* Subject is currently enrolled or plans to enroll in another device or drug clinical trial.\n* Subject is currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment.'}, 'identificationModule': {'nctId': 'NCT00277095', 'acronym': 'ProACT', 'briefTitle': 'ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uromedica'}, 'officialTitle': 'Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'UM02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ProACT (Adjustable Continence Therapy)', 'description': 'Implantation with ProACT (Adjustable Continence Therapy), Single Arm', 'interventionNames': ['Device: ProACT (Adjustable Continence Therapy)']}], 'interventions': [{'name': 'ProACT (Adjustable Continence Therapy)', 'type': 'DEVICE', 'otherNames': ['ProACT,Adjustable Incontinence therapy for Males'], 'description': 'Implantable device to reduce urinary stress incontinence', 'armGroupLabels': ['ProACT (Adjustable Continence Therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'The Pelvic Clinic', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Indian River Urology', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '60901', 'city': 'Kankakee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Urological Surgeons', 'geoPoint': {'lat': 41.12003, 'lon': -87.86115}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro Urology', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '64123', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Urology Care', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': 'V8T5G1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Can-Med Clinical Research Inc.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'J1H5N4', 'city': 'Fleurimont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUS-Fleurimont', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}, {'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Urology Bay of Plenty (formerly Promed Urology)', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}], 'overallOfficials': [{'name': 'Tim Cook, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uromedica, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uromedica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}