Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 4:13 PM
Study NCT ID:
NCT06954233
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voiding and Erectile Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013736', 'term': 'Testicular Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery', 'timeFrame': '6 months', 'description': 'Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery'}, {'measure': 'Change in post-void residual volume (PVR) before and after RPLND surgery', 'timeFrame': '6 months', 'description': 'Change in post-void residual volume (PVR) before and after RPLND surgery'}, {'measure': 'Change in total IPSS score before and after RPLND surgery', 'timeFrame': '6 months', 'description': 'Patients will complete International Prostate Symptom Score (IPSS) questionnaire to assess urinary function before and after surgery'}, {'measure': 'Change in ICIQ-MLUTS score before and after RPLND surgery', 'timeFrame': '6 months', 'description': 'Patients will complete Incontinence Questionnaire - Male Lower Urinary Tract Symptoms - ICIQ-MLUTS questionnaire to assess urinary function before and after surgery'}], 'secondaryOutcomes': [{'measure': 'Change in IIEF-5 questionnaire before and after RPLND surgery', 'timeFrame': '6 months', 'description': 'Patients will complete International Index of Erectile Function - IIEF-5 questionnaire before and after surgery to assess erectile function'}, {'measure': 'Change in MSHQ-EjD questionnaire before and after RPLND surgery', 'timeFrame': '6 months', 'description': 'Patients will complete Male Sexual Health Questionnaire Ejaculatory Dysfunction - MSHQ-EjD questionnaire before and after surgery to assess erectile function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Testicular Cancer', 'Retroperitoneal Lymph Node Dissection'], 'conditions': ['Testicular Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate how retroperitoneal lymph node dissection (RPLND), a surgical treatment for testicular cancer, may affect urinary and sexual functions in men. RPLND involves the removal of lymph nodes from the abdominal area and is sometimes necessary in patients who are not eligible for chemotherapy or who have residual disease after chemotherapy. While this surgery is known to carry a risk of affecting ejaculation, its potential impact on other areas such as urination or erection is not well understood.\n\nThe study will prospectively follow adult men undergoing RPLND. It will assess changes in lower urinary tract symptoms, urine flow, ejaculation, erection, and overall quality of life before surgery and during follow-up visits up to 6 months after the operation. Patients will complete standardized questionnaires and undergo simple, non-invasive tests such as urine flow measurement.\n\nBy identifying how RPLND may influence urinary and sexual health, this study seeks to improve understanding of the full range of effects of this treatment. The findings may help clinicians better inform patients before surgery and support improved post-operative care.', 'detailedDescription': 'This is a prospective observational study designed to evaluate the impact of retroperitoneal lymph node dissection (RPLND) on lower urinary tract and sexual function in patients treated for testicular cancer. The study incorporates validated patient-reported outcome measures (PROMs) alongside objective functional assessments to characterize post-RPLND urinary and sexual sequelae over time.\n\nPatients will complete standardized questionnaires preoperatively and at scheduled postoperative intervals, including the International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), International Index of Erectile Function (IIEF-5), Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD), and EQ-5D-5L for health-related quality of life. Objective evaluation will include uroflowmetry and ultrasound-based measurement of post-void residual volume.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult males with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)\n\nExclusion Criteria:\n\n* History of RPLND\n* Lack of consent'}, 'identificationModule': {'nctId': 'NCT06954233', 'acronym': 'VEEF-RPLND-TC', 'briefTitle': 'Voiding and Erectile Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Voiding, Erectile and Ejaculatory Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer', 'orgStudyIdInfo': {'id': 'VEEF-RPLND-TC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult men with testicular cancer undergoing retroperitoneal lymph node dissection', 'description': 'Adult men with testicular cancer undergoing retroperitoneal lymph node dissection will have uroflowmetry performed and will complete questionnaires focusing on urinary, erectile and ejaculatory function before surgery, after surgery and during 6 months follow-up', 'interventionNames': ['Diagnostic Test: Uroflowmetry and questionnaires']}], 'interventions': [{'name': 'Uroflowmetry and questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': 'Uroflowmetry - urine flow assessment Questionnaires: IPSS, ICIQ-MLUTS, IIEF-5, MSHQ-EjD, EQ-5D-5L', 'armGroupLabels': ['Adult men with testicular cancer undergoing retroperitoneal lymph node dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30-688', 'city': 'Krakow', 'state': 'Malopolska', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna K. Czech, M.D.', 'role': 'CONTACT', 'email': 'aka.czech@uj.edu.pl', 'phone': '+48124002500'}], 'facility': 'Jagiellonian University Medical College', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'centralContacts': [{'name': 'Anna K. Czech, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'aka.czech@uj.edu.pl', 'phone': '+48124002500'}, {'name': 'Jakub Frydrych, M.D.', 'role': 'CONTACT', 'email': 'frydrych.jf@gmail.com', 'phone': '+48124002500'}], 'overallOfficials': [{'name': 'Anna K. Czech, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna K. Czech, MD', 'investigatorAffiliation': 'Jagiellonian University'}}}}