Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 3:26 AM
Study NCT ID:
NCT05578157
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Demographic data', 'timeFrame': '1 year', 'description': 'age, BMI, surgeries, comorbidities (diabetes, hypertension, hyperlipidemia), medication, status of smoking and alcohol consumption'}], 'primaryOutcomes': [{'measure': 'Detectability absence nocturnal erections', 'timeFrame': '9 hours', 'description': 'Visual detectability of the presence and absence of nocturnal erections in overnight penile temperature measurements'}, {'measure': 'Penile temperature REM-sleep', 'timeFrame': '9 hours', 'description': 'Maximal variation in penile temperature during REM-sleep in case of presence and absence of nocturnal erections'}, {'measure': 'Penile temperature nocturnal erection', 'timeFrame': '9 hours', 'description': 'Maximal variation in penile temperature during nocturnal erections in men aged 55 - 70 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction', 'Nocturnal erection', 'RigiScan', 'Penile temperature'], 'conditions': ['Erectile Dysfunction', 'Erectile Dysfunction Following Radical Prostatectomy']}, 'descriptionModule': {'briefSummary': 'Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. The question has arisen whether the penile temperature methodology is also capable to detect the absence of nocturnal erections, which is essential for clinical implementation in erectile dysfunction diagnostics. The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. Furthermore, the MENDiP study functions as a first pilot trial to investigate the effect of age on the penile temperature during nocturnal erections in test subjects with normal erectile functioning. This is done in an observational study with a longitudinal design in which pre- and postoperative ambulatory overnight measurements are performed in patients, aged 55 - 70 years with preoperative normal sexual functioning, undergoing a non- or unilateral nerve-sparing robot assisted radical prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fifteen patients, aged 55 - 70 years, who will undergo a non- or unilateral-nerve-sparing robot assisted radical prostatectomy will be included in case preoperative normal erectile functioning and postoperative complete impotence at three months after surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Preoperative measurement:\n\n * Aged 55 - 70 years\n * Prostatecancer patients undergoing a non-/unilateral-nerve-sparing radical prostatectomy (RARP)\n * Pre-operative IIEF-5 score \\> 21\n2. Postoperative measurement\n\n * Inclusion criteria of pre-operative measurement\n * Preoperative penile temperature increase during first nocturnal erection of minimally 0.4 degrees Celsius\n * Post-operative IIEF-5 score \\< 12 with absence of morning erections\n\nExclusion Criteria:\n\n* Test subjects who are unwilling to sign informed consent\n* Test subjects with erectile dysfunction before RARP (IIEF-5 score of below 22)\n* (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II. These conditions might influence penile blood circulation and therefore the accuracy of the study outcomes.\n* (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea\n* Usage of sleeping pills or benzodiazepines.\n* Postoperative results will be excluded from the study in case of presence of nocturnal erections according to the RigiScan data.'}, 'identificationModule': {'nctId': 'NCT05578157', 'acronym': 'MENDiP', 'briefTitle': 'MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'ABR: 82813'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Age 55 - 60 years', 'interventionNames': ['Diagnostic Test: Feeling Hot sensor']}, {'label': 'Group 2', 'description': 'Age 60 - 65 years', 'interventionNames': ['Diagnostic Test: Feeling Hot sensor']}, {'label': 'Group 3', 'description': 'Age 65 - 70 years', 'interventionNames': ['Diagnostic Test: Feeling Hot sensor']}], 'interventions': [{'name': 'Feeling Hot sensor', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3435CM', 'city': 'Nieuwegein', 'state': 'Utrecht', 'country': 'Netherlands', 'contacts': [{'name': 'Hille Torenvlied, MSc', 'role': 'CONTACT', 'email': 'h.torenvlied@antoniusziekenhuis.nl', 'phone': '+31883202500'}, {'name': 'Karlijn van Adrichem, BSc.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jack Beck, dr., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'centralContacts': [{'name': 'Hille Torenvlied, MSc.', 'role': 'CONTACT', 'email': 'h.torenvlied@antoniusziekenhuis.nl', 'phone': '+31883202500'}], 'overallOfficials': [{'name': 'Jack Beck, dr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc.', 'investigatorFullName': 'Hille Torenvlied', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}