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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEcole Polytechnique Fédérale de Lausanne

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • WaveWriter Alpha™ neurostimulation system

Treatment groups

3 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ecole Polytechnique Fédérale de Lausanne

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Sponsor institution