NCT06845904 Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
| NCT ID | NCT06845904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne |
| Condition | Spinal Cord Injuries (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2025-03-10 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial aims to assess the preliminary safety and efficacy of Epidural Electrical Stimulation (EES) therapy in managing lower urinary tract dysfunction in individuals with sub-acute or chronic spinal cord injury (SCI). The study evaluates the therapy's potential to improve urinary function and prevent neurogenic detrusor overactivity, ultimately seeking to enhance quality of life for individuals with SCI.
Eligibility Criteria
Inclusion Criteria: * Age 18 or older; * Must provide and sign the Informed Consent Form prior to any study-related procedures; * Spinal cord injury lesion level above T11 (inclusive); * SCI graded as AIS- B, C or D; * SCI ≥ 6 months; * Confirmed lower urinary tract dysfunction during urodynamic assessment (NDO, DSD); * Intolerant, refractory or inefficient to conservative treatment options such as medications and behavioural management; * Using intermittent self-catheterization; * Stable medical, physical and psychological condition as considered by the investigators; * Able to understand and interact with the study team in French or English; * Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments; Exclusion Criteria: * Botulinum toxin vesical injections in the previous 6 months; * Presence of non-pharmacological treatments for lower urinary tract dysfunction (e.g. sacral nerve stimulation); * Does have or needs a suprapubic catheter or bladder indwelling catheter; * Presence of upper urinary tract dilatation or bladder or renal stones; * Presence of urethral stricture or significant benign prostate hyperplasia; * Presence of significant pressure ulcers; * Previous lower urinary tract surgery; * Presence of Autonomic Dysreflexia during urodynamic test; * Recurrent and symptomatic urinary tract infection (more than 3 per year); * Presence of intrathecal baclofen pump; * Diseases and conditions that would increase the morbidity and mortality of spinal surgery; * Other clinically significant concomitant disease states (e.g., syringomyelia, bladder cancer, renal failure, hepatic dysfunction, cardiovascular disease, etc.); * The inability to withhold antiplatelet/anticoagulation agents perioperatively; * Presence of pacemakers for cardiac conditions; * Other conditions that would make the subject unable to participate in testing in the judgement of the investigators; * Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding; * Lack of acceptable or highly effective method of contraception for women of childbearing capacity; * Intention to become pregnant during the course of the study; * Inability to follow the procedures of the study, e.g. due to language problems, mental illness, psychological disorders, or dementia of the participant; * Participation in another study with investigational drug or device within the 30 days preceding and during the present study; * Have any indication that would require Magnetic Resonance Imaging (MRI) * Is the investigator himself, his/her family members, employees or other dependent persons.
Contact & Investigator
Jocelyne Bloch, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier universitaire vaudois (CHUV)
Frequently Asked Questions
Who can join the NCT06845904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06845904 currently recruiting?
Yes, NCT06845904 is actively recruiting participants. Contact the research team at jocelyne.bloch@chuv.ch for enrollment information.
Where is the NCT06845904 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06845904 clinical trial?
NCT06845904 is sponsored by Ecole Polytechnique Fédérale de Lausanne. The principal investigator is Jocelyne Bloch, MD at Centre hospitalier universitaire vaudois (CHUV). The trial plans to enroll 3 participants.