Epidural electrical stimulation for bladder control after spinal cord injury

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

This study will try epidural electrical stimulation to improve bladder control in adults with sub-acute or chronic spinal cord injury who have neurogenic urinary dysfunction and use intermittent catheterization.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ecole Polytechnique Fédérale de Lausanne (Academic / other)
• Locations: 1 site (Lausanne, Canton of Vaud)
• Trial ID: NCT06845904 on ClinicalTrials.gov

What this trial studies

This single-center interventional study uses the WaveWriter Alpha neurostimulation system to deliver epidural electrical stimulation aimed at improving lower urinary tract function in people with spinal cord injury. Eligible participants are adults with lesion level at or above T11, AIS B–D, at least six months post-injury, and documented neurogenic detrusor overactivity or detrusor-sphincter dyssynergia who remain refractory or intolerant to conservative treatments. Outcomes include preliminary safety measures and urodynamic and clinical measures of urinary function over a prespecified follow-up period. Recent botulinum toxin injections, existing sacral neuromodulation, or need for a suprapubic catheter are among exclusion criteria, and procedures and follow-up occur at CHUV in Lausanne.

Who should consider this trial

Good fit: Adults (≥18 years) with sub-acute or chronic spinal cord injury at or above T11, AIS B–D, at least six months post-injury, confirmed neurogenic bladder dysfunction (NDO or DSD), using intermittent self-catheterization, and refractory or intolerant to conservative treatments are ideal candidates.

Not a fit: Patients who recently received botulinum toxin injections, have other implanted neuromodulation devices (e.g., sacral nerve stimulation), require a suprapubic catheter, or have unstable medical/psychiatric conditions are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve continence, reduce urinary tract infections and the need for some medications or invasive bladder procedures, and enhance quality of life for people with SCI.

How similar studies have performed: Small, early studies of epidural stimulation for autonomic and bladder function have shown promising signals but controlled evidence is still limited, making this a relatively novel application.

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.

Where this trial is running

Lausanne, Canton of Vaud

• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)

Study contacts

• Principal investigator: Jocelyne Bloch, MD — Centre hospitalier universitaire vaudois (CHUV)
• Study coordinator: Jocelyne Bloch, MD

Conditions Spinal Cord Injuries; Spinal Cord Injury