Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function o… (NCT06347575) | Clinical Trial Compass
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Stopped: The company that supplies the Medical Device has withdrawn.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 range
18 Years – 45 Years
Sex
MALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.