Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-20 @ 10:46 PM
Study NCT ID:
NCT05771168
Status:
RECRUITING
Last Update Posted:
2023-03-16
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery for Male Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016741', 'term': 'Urinary Sphincter, Artificial'}, {'id': 'D053825', 'term': 'Suburethral Slings'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2027-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-05', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-03-05', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate (cure plus improvement)', 'timeFrame': '5-years after surgery', 'description': 'Will be obtained through patient 24-hour pad use. Cure rate is defined as urinary continence with no need for use of pads or the use of 1 light security pad.'}], 'secondaryOutcomes': [{'measure': 'Time being continent', 'timeFrame': '12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years', 'description': 'Interval being continent after surgery to the date of incontinence recurrence. Patients who die will be censored at time of death. Overall time of being continent will be presented using the Kaplan-Meier curve.'}, {'measure': 'Time being revision-free', 'timeFrame': '12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years', 'description': 'Interval from the date of surgery to the date of revision.Patients who die will be censored at time of death. Overall time of being revision-free will be presented using the Kaplan-Meier curve.'}, {'measure': 'Revision-free rate', 'timeFrame': '5-years after surgery', 'description': 'Evaluation of revision-free rate at 5 years of study follow-up'}, {'measure': 'Patient-reported quality of life', 'timeFrame': '12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years', 'description': 'The change in the results of quality of life questionnaires (EuroQol Group EQ-5D-5L) compared with baseline over time and correlations with the primary outcome. EuroQol Group EQ-5D-5L describe health state with 5 levels (level 1 indicating no problem, level 2 indicating slight problems, level 3 indicating moderate problems, level 4 indicating severe problems, level 5 indicating unable to/extreme problems) and with a scale numbered from 0 to 100 (100 means the best health you can imagine and 0 means the worst health you can imagine)'}, {'measure': 'Post-operative general adverse events', 'timeFrame': '12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years', 'description': 'Post-operative general adverse events related to the surgical procedure or the sling/sphincter (e.g. urinary retention, scrotal hematoma, perineal pain, hematuria, or other general problems)'}, {'measure': 'Post-operative specific adverse events', 'timeFrame': '12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years', 'description': 'Post-operative specific adverse events related to the surgical procedure or the sling/sphincter (e.g. pump/reservoir/cuff failure, erosion of the device through the skin or urethra)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary incontinence', 'Male incontinence', 'Post-prostatectomy incontinence', 'Radical prostatectomy', 'Male sling', 'Artificial urinary sphincter'], 'conditions': ['Male Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction ofâ„ 50% of the number of pads with use of no more than two pads.', 'detailedDescription': 'Through the use of a prospective registry, the investigators will collect information on patient characteristics, including age (years), weight (kg), length (cm), previous urological surgeries and other surgeries in the pelvic area, radiotherapeutic treatment of the prostate, and other co-morbidities. Also, if applicable, 24h pad test and preoperative urodynamic results, presence of pre-operative urinary tract infections, and results of preoperative cystoscopy will be reported.\n\nThe surgical procedure for treatment of male stress urinary incontinence is according to standard practice. For artificial urinary sphincters, the date and time of surgery, surgeon name, time of shaving, presence of skin wounds, type of prosthesis, cuff location, cuff size, pressure regulating balloon, type of preoperative antibiotics, type of associated procedures will be reported. For slings, similar data will be reported, including type of sling and if there was a release of central tendon.\n\nThe patients will fill in the International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence (UI) Short Form (ICIQ-UI Questionnaire SF), the EuroQol Group Questionnaire (EQ-5D-5L) for the evaluation of the impact of incontinence on Quality of Life, and the Sexual Complaints Screener for Men (SCS-M), the Dyadic Adjustment Scale Italian version (DAS), the International Index of Erectile Function Questionnaire (IIEF-15) and the Hospital Anxiety and Depression Scale (HADS) questionnaire before the operation, at 12 weeks after surgery and at yearly intervals up to and including year 5. The results of questionnaires will be entered into the database.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male patients undergoing surgery for treatment of stress urinary incontinence (AUS or male sling)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients undergoing surgery for stress incontinence using medical devices such as AUS or sling\n* Participant is willing and able to complete the questionnaires and give informed consent for participation in the study\n\nExclusion Criteria:\n\n\\- Participant unable to complete the questionnaires and declining informed consent for participation in the study'}, 'identificationModule': {'nctId': 'NCT05771168', 'acronym': 'SMUI', 'briefTitle': 'Surgery for Male Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'ID 5094'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AUS', 'description': 'Male patients undergoing surgery for stress urinary incontinence using artificial urinary sphincter (AUS)', 'interventionNames': ['Device: Artificial urinary sphincter']}, {'label': 'Sling', 'description': 'Male patients undergoing surgery for stress urinary incontinence using slings', 'interventionNames': ['Device: Male sling']}], 'interventions': [{'name': 'Artificial urinary sphincter', 'type': 'DEVICE', 'description': 'Implantation of peri-urethral artificial urinary sphincter', 'armGroupLabels': ['AUS']}, {'name': 'Male sling', 'type': 'DEVICE', 'description': 'Retrourethral implantation of male sling', 'armGroupLabels': ['Sling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emilio Sacco, Professor', 'role': 'CONTACT', 'email': 'emilio.sacco@policlinicogemelli.it'}, {'name': 'Filippo Marino, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carlo Gandi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Riccardo Bientinesi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Filippo Gavi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UniversitĂ Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Emilio Sacco, Professor', 'role': 'CONTACT', 'email': 'emilio.sacco@policlinicogemelli.it', 'phone': '+390630155290'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sacco Emilio', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}