Preliminary study on the safety and efficacy of epidural electrical stimulation for treating lower urinary tract dysfunctions after spinal cord injury.
Résumé de l'étude
There is no cure for bladder dysfunctions following spinal cord injury. Therefore, individuals with spinal cord injuries often have to use a catheter to empty their bladder. This can be uncomfortable and painful, and can also lead to infections. These individuals may also suffer from overactive bladder syndrome, which means they have a sudden urge to urinate and may experience urinary leakage. Recent studies have shown that electrical stimulation of the spinal cord may help improve bladder control. This technology was initially tested on animals. Preliminary results on bladder function have also been observed in a patient who received an electrical stimulator in the spinal cord region controlling leg movements. In this clinical trial, called ReeVoid, we will study the safety (safety) and efficacy of stimulation of the lower spinal cord region (sacral region) that controls the urinary system in 3 participants. This therapy consists of 2 neurostimulators and 2 electrode fields implanted on the back of the spinal cord. A neurostimulator is a small device that sends electrical impulses. An electrode field is a thin wire that carries electrical impulses to the spinal cord.
(BASEC)
Intervention étudiée
Participation in this study will last 10 months, including 8 weeks of intense participation and 8 months of a lighter follow-up phase. The study includes 6 different phases. Each phase includes different types of sessions and assessments.
1. Eligibility (up to 1 week): At CHUV, the clinical team will check the general health status and the spinal cord injury. They will ask questions about medical history and medications taken. We will also examine how the spinal cord injury affects the participant and bladder function. We will perform certain examinations such as medical imaging and clinical assessments.
2. Referral (up to 2 weeks): Once eligibility is confirmed, we will conduct some tests and ask questions to understand the current bladder function. This serves as a starting point for comparison. The participant will also receive a special mobile application to track these bladder habits on a phone or tablet during these two weeks, in the form of a voiding diary. This will help us detect any changes in bladder function throughout the study.
3. Surgical procedure: The participant will undergo surgery under general anesthesia for the implantation of 2 electrode fields on the spinal cord and 2 neurostimulators in the abdominal region. The procedure will take place at CHUV.
4. Configuration phase (up to 4 weeks): The researchers will test different stimulation parameters on the medical device to see what works best to improve your bladder control, both when the participant needs to empty their bladder (voiding) and when they feel the urge to have a bowel movement (calming). They will adjust the parameters so that the therapy works best. Once the investigator physician has decided that the therapy is safe, participants will be able to use it at home.
5. Follow-up phase (up to 8 months). Participants will be able to use the therapy in their daily lives until the end of the study, if approved by the investigator physician. The research team may need to conduct additional configuration sessions to adjust the parameters of the medical device.
6. End of the study. The medical device may be explanted, inactivated, or kept active for use after the study ends. Participants will continue to use it only if the investigator physician deems it safe and beneficial for them.
Clinical assessments and questionnaires: Throughout the clinical trial, participants will need to undergo clinical assessments at CHUV: before the operation, and at 3 different times after the operation. They will also fill out questionnaires and keep an electronic voiding diary with information about bladder function at home.
(BASEC)
Maladie en cours d'investigation
Lower urinary tract dysfunctions after spinal cord injury
(BASEC)
1. 18 years or older ; 2. Must provide and sign the informed consent form prior to any study-related procedures ; 3. Spinal cord injury level above T11 (inclusive) ; 4. Spinal cord injury classified as ASIA B, C, or D ; 5. Injury age ≥ 6 months ; 6. Confirmed vesico-sphincter disorders during urodynamic assessment (NDO, DSD) ; 7. Ineffectiveness or intolerance of ongoing treatments ; 8. Use of intermittent urinary catheterization ; 9. Stable medical, physical, and psychological conditions according to investigators ; 10. Able to understand and interact with the study team in French or English ; 11. Agree to comply in good faith with all study conditions and to attend all scheduled appointments ; (BASEC)
Critères d'exclusion
1. Injection of botulinum toxin non-bladder and bladder in the last 6 months ; 2. Presence of non-pharmacological treatments for lower urinary tract dysfunction (e.g., sacral nerve stimulation) ; 3. Possession or need for a suprapubic catheter or indwelling catheter ; 4. Presence of dilation of the upper urinary tract or bladder or kidney stones ; 5. Presence of urethral stricture or benign prostatic hyperplasia ; 6. Presence of pressure sores; 7. Previous surgery of the lower urinary tract ; 8. Presence of autonomic dysreflexia during a urodynamic test ; 9. Recurrent and symptomatic urinary infections (more than 3 per year) ; 10. Presence of an intrathecal baclofen pump ; 11. Conditions that would increase morbidity and mortality of spinal surgery ; 12. Other clinically significant concomitant conditions (e.g., syringomyelia, bladder cancer, renal failure, liver dysfunction, cardiovascular disease, etc.) ; 13. Contraindication to antiplatelet or anticoagulant therapy during the perioperative period ; 14. Presence of pacemakers ; 15. Other conditions that, in the opinion of the investigators, would render the subject unable to participate in the tests ; 16. Pregnant women (pregnancy test mandatory for women of childbearing age) or breastfeeding ; 17. Absence of safe contraception for women of childbearing age ; 18. Intention to become pregnant during the study duration ; 19. Inability to follow study procedures, e.g., due to language issues, mental illness, psychological disorders, or dementia of the participant ; 20. Participation in another study with an experimental drug or device within 30 days prior to and during this study ; 21. Condition requiring magnetic resonance imaging (MRI). 22. It must not be the investigator themselves, family members, employees, or other dependent persons. (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
Ecole Polytechnique Fédérale Lausanne (EPFL)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Jocelyne Bloch
+41 79 556 29 51
neurorestore.studies@clutterchuv.chCentre Hospitalier Universitaire Vaudois
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
19.02.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Study on preliminary safety and efficacy of epidural electrical stimulation to manage lower urinary tract dysfunction after spinal cord injury. (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible