Spinal implant aims to restore bladder control after paralysis

NCT ID NCT06845904

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 3 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

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