An interventional study of WaveWriter Alpha™ neurostimulation system in Spinal Cord Injuries (SCI) and Spinal Cord Injury, sponsored by Ecole Polytechnique Fédérale de Lausanne. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Ecole Polytechnique Fédérale de Lausanne · Not applicable, Interventional, and Treatment
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.
The consequences of a Spinal Cord Injury (SCI) are dramatic. SCI leads to impairment of motor, sensory, and autonomic systems, dysregulating almost every bodily function below the level of injury. The majority of research on SCI focuses on the restoration of movement. However, the disruption of pathways controlling the bladder leads to less-appreciated symptoms that require life-long clinical management, are the one of the main cause of rehospitalization, and incurred the largest healthcare costs after SCI. Neurogenic bladder issues, such as neurogenic detrusor overactivity (NDO) leading to incontinence, detrusor-sphincter dyssynergia (DSD) and decreased bladder compliance, are currently treated with intermittent catheterization, anticholinergic medications, botulinum toxin injections directly into the detrusor and ultimately irreversible major surgical interventions. Despite improvement in bladder management provided by these clinical and interventional tools, people with SCI still experience recurrent urinary tract infections from repeated catheterization, incontinence events impacting their professional and intimate life, side-effects from anti-cholinergic medication. It therefore comes as no surprise that people with spinal cord injury prioritize the treatment of lower urinary tract dysfunction as one of their top health priorities.
The investigators reasoned that the neuroprosthetic management of micturition and urinary continence may overcome many of the existing limitations of current clinical management strategies. To test this idea, the investigators have developed a neuroprosthetic system based on Epidural Electrical Stimulation (EES) of the spinal cord that restored micturition (EESVOIDING) and improve urinary continence by reducing detrusor overactivity (EESSTORAGE) in preclinical models of SCI. Development of this neuroprosthetic system combined with rigorous experiments led to the identification of the locations and parameters of EES that can activate the detrusor while relaxing the external urethral sphincter (EUS). The investigators also gathered preliminary evidence on the key features of this therapeutic strategy in one patient with low-thoracic motor-complete SCI (T10, AIS-B) who was implanted with a neuroprosthetic system on the lumbosacral spinal cord (covering T12 to S1) to restore walking (STIMO clinical Trial, NCT02936453). Stimulation of the sacral spinal cord of this participant resulted in controlled detrusor contraction leading to voiding. Consequently, the investigators hypothesize that EES has the potential to become the first-line treatment for bladder dysfunction in people with chronic or sub-acute SCI. However, its clinical deployment relies on selective stimulation paradigms and development of medical-grade implantable spinal-cord stimulation technologies that are optimized for bladder management.
The ReeVoid clinical study will enroll 3 participants, who will be implanted with a system to apply EES to stimulate the spinal circuits involved in the control of the bladder. The aim of the study is to manage lower urinary tract functions with EES, including supporting voiding and preventing neurogenic detrusor overactivity incontinence (NDOI) in individuals with sub-acute or chronic spinal cord injury located above T11 and who suffer from lower urinary tract dysfunction. Two electrode paddle leads will be implanted. The first one will cover the dorsal root entry zone of the lumbosacral segments (L4-S5), while the second will aim to target the S1-S4 roots where they exit the spinal canal in the lower vertebras, and thus to maximise selective recruitment of the dorsal roots involved in the control of the detrusor and urethral sphincter muscles. Each paddle lead will be connected to a neurostimulator located subcutaneously in the region of the abdomen.
This therapy aims also to have a positive impact on other neurological functions such as sexual function, bowel management and muscle tone normalization (reduced spasticity).
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 3 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Ecole Polytechnique Fédérale de Lausanne is the lead sponsor of 21 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants enrolled in the study will receive the same intervention. This clinical trial evaluates a novel therapy using a CE-marked medical device employed off-label. Participants will undergo implantation of a neurostimulation system designed to deliver electrical stimulation to the spinal cord. The therapy aims to improve control over detrusor and urethral sphincter muscles by targeting the associated nerves.
Device: WaveWriter Alpha™ neurostimulation system
Two 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.
Time frame: From enrolment through study completion, an average of 10 months.
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.
Time frame: Pre-implantation (up to 3 weeks pre-implantation) and at the End of Study phase (lasting up to 1 week at 9 months)
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.
Time frame: Pre-implantation (up to 2 weeks pre-implantation) and at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
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.
Time frame: Pre-implantation (up to 2 weeks pre-implantation), Mapping phase (1 week post-implantation and lasting up to 1 month), at Follow-up phase and End of Study phase (at months 3 and 6 post-implantation and lasting up to 1 week)
Renal ultrasound
Renal ultrasound is used to monitor the kidneys, ureters, and bladder, providing valuable information about kidney size, shape, and position.
Time frame: Pre-implantation (up to 3 weeks before implantation), Mapping phase (1 week post-implantation and lasting up to 1 month), Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
Urine sampling
Urine sampling is taken to confirm the absence of any urinary tract.
Time frame: Pre-implantation (up to 3 weeks pre-implantation) and upon suspicion
24 hours urine collection
24 hours urine collection is taken to quantify the spot albumin and creatinine in the urine. These parameters are used to confirm the absence of any renal dysfunctions.
Time frame: Pre-implantation (up to 3 weeks pre-implantation) and at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
Blood samples
Blood sampling (max 20mL) is taken to quantify creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and cystatin C. These parameters are used to confirm the absence of any renal dysfunctions.
Time frame: Pre-implantation (up to 3 weeks pre-implantation) and at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
Cystometry
A catheter is inserted into the bladder to measure intravesical pressure while the bladder is filled with sterile fluid at a controlled rate. Simultaneously, abdominal pressure is monitored to assess detrusor pressure and bladder compliance. Cystometry helps identify neurogenic detrusor overactivity, bladder capacity, and compliance.
Time frame: Pre-implantation (up to 3 weeks and up to 2 weeks pre-implantation), Mapping phase (1 week post-implantation and lasting up to 1 month), at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
Imaging (with contrast agent)
X-Ray (or fluoroscopy) can be taken, with imaging contrast agents, to provide visualization of the urinary tract and/or catheter placements (optional).
Time frame: Pre-implantation (up to 3 weeks and up to 2 weeks pre-implantation), Mapping phase (1 week post-implantation and lasting up to 1 month), at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
Pressure-flow study
During voiding, simultaneous measurements of detrusor pressure and urinary flow rate are recorded. This aids in diagnosing detrusor-sphincter dyssynergia (DSD), evaluating voiding efficiency, and identifying obstructive patterns.
Time frame: Pre-implantation (up to 3 weeks and up to 2 weeks pre-implantation), Mapping phase (1 week post-implantation and lasting up to 1 month), at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
Electromyography (EMG)
Surface electrodes or specialized catheters are used to record electrical activity in the bladder and external urethral sphincter muscles. EMG helps detect detrusor-sphincter dyssynergia (DSD) by assessing the coordination between detrusor and sphincter activity during filling and voiding.
Time frame: Pre-implantation (up to 3 weeks and up to 2 weeks pre-implantation), Mapping phase (1 week post-implantation and lasting up to 1 month), at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
Flowmetry - Urethral pressure profile (UPP)
A catheter-mounted pressure sensor is withdrawn slowly from the bladder through the urethra, recording pressure changes along the urethral length. UPP assists in evaluating sphincter function and diagnosing urethral obstruction.
Time frame: Pre-implantation (up to 3 weeks and up to 2 weeks pre-implantation), Mapping phase (1 week post-implantation and lasting up to 1 month), at Follow-up phase and End of Study phase (at months 3, 6 and 9 post-implantation and lasting up to 1 week)
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.
Time frame: Pre-implantation (up to 2 weeks pre-implantation) and monthly for 9 months post-implantation
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).
Time frame: Pre-implantation (up to 2 weeks pre-implantation) and monthly for 9 months post-implantation
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.
Time frame: Pre-implantation (up to 2 weeks pre-implantation) and monthly for 9 months post-implantation
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.
Time frame: Pre-implantation (up to 2 weeks pre-implantation) and monthly for 9 months post-implantation
ADFSCI (Autonomic Dysreflexia following SCI)
The ADFSCI is a 24-item questionnaire consisting of four parts: demographics, medication, AD (Autonomic Dysreflexia) and hypotension. The AD section (10 items) and hypotension section (7 items) assess the severity and frequency of hyper- or hypotensive symptoms, such as headache, goosebumps, dizziness, and light-headedness, in different circumstances. Each item is scored on a 5-point scale (0 to 4), with higher scores indicating greater severity and frequency of symptoms.
Time frame: Pre-implantation (up to 3 weeks pre-implantation) and monthly for 9 months post-implantation
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Feb 2027, 23 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 23 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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Ecole Polytechnique Fédérale de Lausanne