protocolSection identificationModule nctId: NCT06347575, orgStudyIdInfo id: APHP230522, briefTitle: Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients, acronym: CAVERSTIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: Comphya SA, descriptionModule briefSummary: The main objective of the study is to assess the safety and tolerability of cavernous nerve electrical stimulation in patients with spinal cord injured (SCI) by assessing and measuring complications.As the secondary objectives, despite the limited cohort size, this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse, as well as to assess patient's satisfaction using:* Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device.* Subjective assessment of the erectile function with validated questionnaires:  1. A 6-item self-report instrument assessing male erectile function (Erectile Function domain of the International Index of Erectile Function, IIEF-EF);  2. A log-diary five item questionnaire completed after each sexual attempt (Sexual Encounter Profile, SEP);  3. A self-reporting measure that scores erection hardness on a 4-point scale (Erection Hardness Score, EHS);  4. The Global Assessment Question (GAQ).In addition, the study aims to refine the method of implantation (step-by-step delineation of all technical approaches for device implantation, including duration of surgical procedure, blood loss, methods to access the periprostatic region, tissue dissection, device placement and fixation) prior to planning for larger scale clinical investigation., conditionsModule conditions: Spinal Cord Injuries, conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Implantation of the caverStim device, outcomesModule primaryOutcomes measure: Safety evaluation, primaryOutcomes measure: Pain assessement, primaryOutcomes measure: Complications related to implantation surgery, secondaryOutcomes measure: Evaluation of IIEF-EF, secondaryOutcomes measure: Evaluation of EHS, secondaryOutcomes measure: Evaluation of SEP, secondaryOutcomes measure: Evaluation of GAQ, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of neurology-urology-andrology, Raymond Poincaré hospital - APHP, city: Garches, zip: 92380, country: France, geoPoint lat: 48.84226, lon: 2.18232, locations facility: Department of Urology, La pitié Salpêtrière Hospital - APHP, city: Paris, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False