Epidural electrical stimulation for bladder control after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jocelyne.bloch@chuv.ch
• Phone: +41 79 556 29 51

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.