WithdrawnNot Applicable

Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients

Stopped: The company that supplies the Medical Device has withdrawn.

France0Started 2024-05

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Subjects have to fulfill all of the following inclusion criteria before being included in the run-in phase: * Written informed consent obtained from the subject; * Men between the age of 18 to 45 years old with supra sacral spinal cord injury and below T6 as the upper limit; * Men with stable spinal cord injury, which occurred at least 6 months prior to study enrolment; * Men with documented neurogenic overactive detrusor activity according to urodynamic testing in their files; * Have a monogamous relationship with a female sexual partner (vaginal penetration required for several of the primary efficacy variables) for at least 6 months prior to screening * Men with an insufficient response to PDE5-Is and interested in treating erectile dysfunction; * Ability to understand and follow study-related instructions. Subjects have to fulfill all of the following inclusion criteria before being included in the implantation phase: * At least 4 sexual intercourse attempts during the 4-week run-in phase with use of 100 mg sildenafil approximately 1 hour before attempting intercourse * IIEF-EF score \< 17 at the end of the run-in phase; * At least 50% of attempts at sexual intercourse during the run-in phase had been unsuccessful i.e. the following question in the SEP Diary had to be answered with "No": "Did your erection last long enough for you to have successful intercourse?" (SEP3: success in maintenance of erection). Exclusion Criteria: All exclusion crite…

What they're measuring

Safety evaluation

Timeframe: at 6 months

Pain assessement

Timeframe: at 6 months

Complications related to implantation surgery

Timeframe: at 6 months

Trial details

NCT IDNCT06347575

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.