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

NCT06347575 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Implantation of the caverStim device

Implantation of caverStim in SCI patients.

Sponsors & Collaborators

  • Comphya SA

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • François Giuliano, MD, PhD · Department of neurology-urology-andrology, Raymond Poincaré hospital - APHP

  • Emmanuel CHARTIER-KASTLER, MD, PhD · Department of Urology, La Pitié-Salpétrière hospital - APHP

  • Anne Charlotte DENORMANDIE, MD · Department of Urology, La Pitié-Salpétrière hospital - APHP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06347575 on ClinicalTrials.gov