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.
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;
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;
Single group
WaveWriter Alpha™ neurostimulation system
DeviceTwo Boston Scientific WaveWriter Alpha™ Implantable Pulse Generators (IPGs) will be implanted and connected to CoverEdge™ or CoverEdge™ X 32 Surgical Paddle Leads. The leads are positioned to enable targeted stimulation of the spinal cord to optimize control of urinary functions.
Occurrence of serious adverse events and adverse events.
Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the use of the investigational.
ASIA impairment scale - International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.
Spasticity assessment (Modified Ashworth Scale - MAS)
Resistance of a muscle to a passive range of motion about a single joint, measured using the Modified Ashworth Scale (MAS), a 6-point scale with scores of 0, 1, 1+, 2, 3, and 4. A score of 0 indicates no increase in muscle tone, while a score of 4 indicates the affected part is rigid in flexion or extension. Higher scores indicate worse spasticity.
Daily Bladder related diary
Self-reported measures including urinary related events (voiding volume by catheterization and electrical stimulation, frequency, daytime and during night frequency, catheterization and volume of residual volume after stimulation, symptomatic urinary tract infection, use of stimulation) reported on a tracking app to quantify changes before and after implantation.
Renal ultrasound
Renal ultrasound is used to monitor the kidneys, ureters, and bladder, providing valuable information about kidney size, shape, and position.
NBDS (Neurogenic Bowel Dysfunction Score)
10-item questionnaire that is associated with impaired QoL caused by bowel symptoms. The NBD weighted score ranges between 0 and 47 points. A higher overall NBD score indicates more severe bowel symptoms.
NBSS (Neurogenic Bladder Symptom Score)
The NBSS consists of 24 items across three domains: Incontinence (scored 0-29); Storage and Voiding (scored 0-22); and Consequences (scored 0-23). For all domains, a higher score represents a worse symptom burden or QoL (quality of life).
SF-Qualiveen (QUALIVEEN Short Form)
To assess health-related quality of life of patients with urinary disorders in neurologic conditions. The 8-item questionnaire include bother with limitations (2 items), frequency of limitations (2 items), fears (2 items), and feelings (2 items). Items 1-6 are scored on a 5-point scale (0 to 4), with higher scores indicating a greater negative impact on quality of life. Items 7-8 are scored on a 5-point reverse scale (0 to 4), where higher scores indicate less impact on quality of life.
IIEF/FSFI (International Index of Erectile Function-5/Female Sexual Function Index)
IIEF-15: A 15-item questionnaire covering five domains: erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). Scores range from 5 to 25, with erectile dysfunction (ED) classified as severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25). Higher scores indicate better erectile function. FSFI: A 19-item self-reported measure assessing six domains: desire, subjective arousal, lubrication, orgasm, satisfaction, and pain. Each item is scored on a 5-point scale (1 to 5), with higher scores indicating better sexual function.
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
