Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-30 @ 2:38 PM
Study NCT ID:
NCT06845904
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
Sponsor:
Ecole Polytechnique Fédérale de Lausanne
Organization:
Study Overview
Official Title:
Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReeVoid
Brief Summary:
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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: