Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-02 @ 9:43 PM
Study NCT ID:
NCT03302169
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2017-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}, {'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': 'D011469', 'term': 'Prostatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072229', 'term': 'Posterior Cruciate Ligament Reconstruction'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective randomized controlled trial to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2017-09-30', 'lastUpdatePostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month', 'timeFrame': '1 month after surgery', 'description': 'Absence of urinary incontinence (number of PADs/d)'}, {'measure': 'Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month', 'timeFrame': '6 months after surgery', 'description': 'Absence of urinary incontinence (number of PADs/d)'}], 'secondaryOutcomes': [{'measure': 'early urinary recovery quantification in Grams (PAD-test 24h)', 'timeFrame': 'one day before catheter removal, 2 weeks before and 1 month before', 'description': 'PAD-test during the first month after surgery'}, {'measure': 'Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month', 'timeFrame': '12 months after surgery', 'description': 'Absence of urinary incontinence (number of PADs/d)'}, {'measure': 'Erectile function', 'timeFrame': '1, 6 and 12 months', 'description': 'SHIM assessment'}, {'measure': 'Quality of life I: urinary and bowel function', 'timeFrame': '1, 6 and 12 months', 'description': 'EPIC-26 urinary and digestive function'}, {'measure': 'Quality of life II: urinary function', 'timeFrame': '1, 6 and 12 months', 'description': 'ICIQ-SF assessment of urinary function'}, {'measure': 'Quality of life III: urinary function', 'timeFrame': '1, 6 and 12 months', 'description': 'IPSS assessment of urinary function'}, {'measure': 'Oncological outcome: Biochemical free-recurrence status', 'timeFrame': '1, 6 and 12 months', 'description': 'serum PSA assessment. Biochemical free-recurrence status = PSA \\<0.2'}, {'measure': 'Anatomopathological parameters: Surgical margins', 'timeFrame': '1 month', 'description': 'Surgery margins in prostatectomy specimens'}, {'measure': 'Anatomopathological parameters: pTNM classification', 'timeFrame': '1 month', 'description': 'Pathological pTNM in prostatectomy specimens'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Urinary incontinence', 'Radical prostatectomy', 'Rhabdosphincter', 'Robotic Surgery'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '35272967', 'type': 'DERIVED', 'citation': 'Salazar A, Regis L, Planas J, Celma A, Trilla E, Morote J. Continence definition and prognostic factors for early urinary continence recovery in posterior rhabdosphincter reconstruction after robot-assisted radical prostatectomy. Post-hoc analysis of a randomised controlled trial. Actas Urol Esp (Engl Ed). 2022 Apr;46(3):159-166. doi: 10.1016/j.acuroe.2021.06.012. Epub 2022 Mar 7. English, Spanish.'}, {'pmid': '33653674', 'type': 'DERIVED', 'citation': 'Salazar A, Regis L, Planas J, Celma A, Santamaria A, Trilla E, Morote J. A Randomised Controlled Trial to Assess the Benefit of Posterior Rhabdosphincter Reconstruction in Early Urinary Continence Recovery after Robot-assisted Radical Prostatectomy. Eur Urol Oncol. 2022 Aug;5(4):460-463. doi: 10.1016/j.euo.2021.02.005. Epub 2021 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. A hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. Continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF, IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the secondary objective will be assessed by SHIM questionnaire.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmation of prostate cancer\n* Localized or locally advanced prostate cancer\n* Informed consent signed\n\nExclusion Criteria:\n\n* Presence of urinary incontinence prior to the procedure\n* Previous radiation therapy of the prostate or pelvis\n* Presence of any prostatic surgery prior to the procedure\n* Prior medical history of psychiatric diseases or drug addiction\n* Any condition that contraindicates a radical prostatectomy'}, 'identificationModule': {'nctId': 'NCT03302169', 'acronym': 'RHABDO-PROST', 'briefTitle': 'Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.', 'orgStudyIdInfo': {'id': 'PR(AG)330/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posterior Rhabdosphincter Reconstruction', 'description': 'Patients in who posterior rhabdosphincter reconstruction is performed', 'interventionNames': ['Procedure: Radical prostatectomy with posterior rhabdosphincter reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Technique', 'description': 'Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique.', 'interventionNames': ['Procedure: Radical prostatectomy without posterior rhabdosphincter reconstruction']}], 'interventions': [{'name': 'Radical prostatectomy with posterior rhabdosphincter reconstruction', 'type': 'PROCEDURE', 'otherNames': ['Rocco reconstruction technique', 'Posterior reconstruction', 'Rocco Stitch'], 'description': 'To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.', 'armGroupLabels': ['Posterior Rhabdosphincter Reconstruction']}, {'name': 'Radical prostatectomy without posterior rhabdosphincter reconstruction', 'type': 'PROCEDURE', 'description': 'Standard technique with a running suture to perform the urethrovesical anastomosis', 'armGroupLabels': ['Standard Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Juan Morote, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospital Vall d'Hebron"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}