Spinal implant aims to restore bladder control after paralysis
NCT ID NCT06845904
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether epidural electrical stimulation can improve bladder function in people with spinal cord injuries. The trial enrolls adults with injuries above T11 who have trouble urinating and rely on catheters. Participants receive an implanted spinal cord stimulator that delivers targeted electrical pulses to the spinal cord. The study measures safety and whether the therapy can prevent dangerous bladder pressure spikes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- epidural electrical stimulation using an implanted spinal cord neurostimulation system
- What this could lead to
- If it works, this approach could offer a way to restore bladder control and reduce urinary complications for people living with spinal cord injuries.
- What could go wrong
- The trial is very small, with only three participants, so results may not apply broadly. Implanting spinal cord stimulators carries risks of infection, lead movement, and surgical complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 3 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITINGLausanne, Canton of Vaud, 1011, Switzerland
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Other studies related to the condition(s) this trial covers.
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- Scientists map the daily rhythms of chronic pain
- Can AI learn to tune spinal cord stimulators?
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