Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury

Launched by ECOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called Epidural Electrical Stimulation (EES) to help people with spinal cord injuries improve their bladder function. The goal is to see if EES can make it easier for individuals with lower urinary tract problems—as a result of spinal cord injuries— to manage their condition and enhance their quality of life. The trial is not yet recruiting participants, but it will include adults aged 18 and older who have experienced a spinal cord injury at or above the T11 level and have had this injury for at least six months.

To participate, individuals need to have ongoing issues with bladder control that haven’t improved with other treatments, like medications or self-catheterization. They must also be in stable health and able to communicate with the study team in either French or English. Participants can expect to receive the EES therapy and will be monitored closely throughout the trial to assess its safety and effectiveness. It’s important to note that there are specific health conditions that would exclude someone from taking part, such as certain previous treatments for bladder issues or other significant medical problems.

Gender

ALL

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.