Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-03-04 @ 10:23 AM
Study NCT ID:
NCT02367404
Status:
UNKNOWN
Last Update Posted:
2016-09-13
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective RCT on Post Prostatectomy Urine Leak
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': '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': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary continence proportion', 'timeFrame': '6 months', 'description': 'Proportion of patient achieving continence at 6 months'}], 'secondaryOutcomes': [{'measure': 'Urinary continence time', 'timeFrame': '6 months', 'description': 'time to achieve continence'}, {'measure': 'Urinary quality of life', 'timeFrame': '6 months', 'description': 'Quality of life tested in relation to incontinence using questionnaire at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nPrimary: Comparison of proportion of patient achieving continence between the four arms at 6 months.\n\nSecondary:\n\n* Comparison of time to achieve continence between the four arms.\n* Comparison of urinary symptoms and quality of life improvement between the four arms.\n* Assessment of adverse events in Duloxetine arms.\n\nPrimary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".\n\nSecondary outcome:\n\n* time to achieve continence\n* Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King\'s Health Questionnaire (KQH).\n* Urinary symptoms measured with International Prostate Symptom Score (IPSS).\n\nNo. of subjects entered: 300 patients informed and included, 240 patients will be randomized.\n\nStatistical methods\n\n* Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.\n* Comparison of quality of life outcomes between the four arms\n* Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer\n\nExclusion Criteria:\n\n1. Prior urethral, bladder or prostate surgery\n2. Pelvic radiotherapy.\n3. Overactive bladder\n4. Known neurological disease associated to LUTS\n5. Hepatic impairment with hepatic insufficiency.\n6. Severe renal impairment (creatinine clearance \\< 30ml/min)\n7. Hypersensitivity to duloxetine\n8. Uncontrolled hypertension\n9. Narrow angle glaucoma\n\n Post-operative criteria:\n10. Post-void residual urine volume \\> 100ml measured 15 days after the RARP'}, 'identificationModule': {'nctId': 'NCT02367404', 'briefTitle': 'Prospective RCT on Post Prostatectomy Urine Leak', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'URO-01-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "Keigel's exercise"}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Duloxetine', 'description': 'Duloxetine 60mg for 3 months', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Duloxetine + PMFT', 'description': 'Duloxetine 60mg for 3 months PMFT weekly for 3 months', 'interventionNames': ['Drug: Duloxetine', 'Behavioral: Pelvic Floor Muscle Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvic Floor Muscle Training', 'description': 'PMFT weekly for 3 months', 'interventionNames': ['Behavioral: Pelvic Floor Muscle Training']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta'], 'description': 'Duloxetine 60mg OD for 3 months', 'armGroupLabels': ['Duloxetine', 'Duloxetine + PMFT']}, {'name': 'Pelvic Floor Muscle Training', 'type': 'BEHAVIORAL', 'otherNames': ['Pelvic Physiotherqpy'], 'description': 'PMFT weekly for 3 months', 'armGroupLabels': ['Duloxetine + PMFT', 'Pelvic Floor Muscle Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Mutualiste montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Rafael Sanchez-Salas, MD', 'role': 'CONTACT', 'email': 'rafael.sanchez-salas@imm.fr', 'phone': '0156616617'}], 'overallOfficials': [{'name': 'Rafael Sanchez-Salas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute Mutualiste Montsouris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}