Spinal Cord Injuries (SCI)ReeVoidNCT06845904

Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury

A study testing WaveWriter Alpha™ neurostimulation system in people with Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injuries (SCI), Spinal Cord Injury
What is being tested?: WaveWriter Alpha™ neurostimulation system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteSwitzerland
Study dates: 10 Mar 2025to Feb 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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);

Show all 11Show fewer

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;

Who cannot join

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;

Show all 22Show fewer

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jocelyne Bloch, MD contact

+41 79 556 29 51

jocelyne.bloch@chuv.ch

Switzerland1 site, 1 recruiting

Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Jocelyne Bloch, Prof. Dr., jocelyne.bloch@chuv.ch
Recruiting

Other trials in Switzerland

About this study

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.

Read the 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).

Conditions: Spinal Cord Injuries (SCI), Spinal Cord Injury
Being tested: WaveWriter Alpha™ neurostimulation system
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WaveWriter Alpha™ neurostimulation systemDevice
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.

Study groups in NCT06845904
Study group	Role	What they receive
All participants	Experimental	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. Receives: Device: WaveWriter Alpha™ neurostimulation system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From enrolment through study completion, an average of 10 months.

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 2025Feb 2027

First posted25 Feb 2025
Study start10 Mar 2025
Primary completionFeb 2027 (estimated)
Study completionFeb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single-site, single-arm, non-blinded, non-randomized, interventional
Masking: None (open label)
Enrolment: 3 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06845904
Sponsor's protocol ID: ReeVoid
Acronym: ReeVoid
Status last verified: Sep 2026
First submitted: 28 Jan 2025
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Perrouin-Verbe B, Labat JJ, Richard I, Mauduyt de la Greve I, Buzelin JM, Mathe JF. Clean intermittent catheterisation from the acute period in spinal cord injury patients. Long term evaluation of urethral and genital tolerance. Paraplegia. 1995 Nov;33(11):619-24. doi: 10.1038/sc.1995.131.
PubMed 8584294
Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR. Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet. 2011 Jun 4;377(9781):1938-47. doi: 10.1016/S0140-6736(11)60547-3. Epub 2011 May 19.
PubMed 21601270
Herrity AN, Williams CS, Angeli CA, Harkema SJ, Hubscher CH. Lumbosacral spinal cord epidural stimulation improves voiding function after human spinal cord injury. Sci Rep. 2018 Jun 6;8(1):8688. doi: 10.1038/s41598-018-26602-2.
PubMed 29875362
Walter M, Lee AHX, Kavanagh A, Phillips AA, Krassioukov AV. Epidural Spinal Cord Stimulation Acutely Modulates Lower Urinary Tract and Bowel Function Following Spinal Cord Injury: A Case Report. Front Physiol. 2018 Dec 18;9:1816. doi: 10.3389/fphys.2018.01816. eCollection 2018.
PubMed 30618826
Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.
PubMed 35132264
Jantz MK, Gopinath C, Kumar R, Chin C, Wong L, Ogren JI, Fisher LE, McLaughlin BL, Gaunt RA. High-density spinal cord stimulation selectively activates lower urinary tract nerves. J Neural Eng. 2022 Nov 22;19(6):066014. doi: 10.1088/1741-2552/aca0c2.
PubMed 36343359
Squair JW, Gautier M, Mahe L, Soriano JE, Rowald A, Bichat A, Cho N, Anderson MA, James ND, Gandar J, Incognito AV, Schiavone G, Sarafis ZK, Laskaratos A, Bartholdi K, Demesmaeker R, Komi S, Moerman C, Vaseghi B, Scott B, Rosentreter R, Kathe C, Ravier J, McCracken L, Kang X, Vachicouras N, Fallegger F, Jelescu I, Cheng Y, Li Q, Buschman R, Buse N, Denison T, Dukelow S, Charbonneau R, Rigby I, Boyd SK, Millar PJ, Moraud EM, Capogrosso M, Wagner FB, Barraud Q, Bezard E, Lacour SP, Bloch J, Courtine G, Phillips AA. Neuroprosthetic baroreflex controls haemodynamics after spinal cord injury. Nature. 2021 Feb;590(7845):308-314. doi: 10.1038/s41586-020-03180-w. Epub 2021 Jan 27.
PubMed 33505019
Soriano JE, Squair JW, Cragg JJ, Thompson J, Sanguinetti R, Vaseghi B, Emery CA, Grant C, Charbonneau R, Larkin-Kaiser KA, Phillips AA, Dujic Z. A national survey of physical activity after spinal cord injury. Sci Rep. 2022 Mar 15;12(1):4405. doi: 10.1038/s41598-022-07927-5.
PubMed 35292668
Hoey RF, Medina-Aguinaga D, Khalifa F, Ugiliweneza B, Zdunowski S, Fell J, Naglah A, El-Baz AS, Herrity AN, Harkema SJ, Hubscher CH. Bladder and bowel responses to lumbosacral epidural stimulation in uninjured and transected anesthetized rats. Sci Rep. 2021 Feb 8;11(1):3268. doi: 10.1038/s41598-021-81822-3.
PubMed 33558526
Herrity AN, Aslan SC, Mesbah S, Siu R, Kalvakuri K, Ugiliweneza B, Mohamed A, Hubscher CH, Harkema SJ. Targeting bladder function with network-specific epidural stimulation after chronic spinal cord injury. Sci Rep. 2022 Jul 1;12(1):11179. doi: 10.1038/s41598-022-15315-2.
PubMed 35778466
Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
PubMed 30382197
Kathe C, Skinnider MA, Hutson TH, Regazzi N, Gautier M, Demesmaeker R, Komi S, Ceto S, James ND, Cho N, Baud L, Galan K, Matson KJE, Rowald A, Kim K, Wang R, Minassian K, Prior JO, Asboth L, Barraud Q, Lacour SP, Levine AJ, Wagner F, Bloch J, Squair JW, Courtine G. The neurons that restore walking after paralysis. Nature. 2022 Nov;611(7936):540-547. doi: 10.1038/s41586-022-05385-7. Epub 2022 Nov 9.
PubMed 36352232
Anderson MA, Squair JW, Gautier M, Hutson TH, Kathe C, Barraud Q, Bloch J, Courtine G. Natural and targeted circuit reorganization after spinal cord injury. Nat Neurosci. 2022 Dec;25(12):1584-1596. doi: 10.1038/s41593-022-01196-1. Epub 2022 Nov 17.
PubMed 36396975
McGee MJ, Amundsen CL, Grill WM. Electrical stimulation for the treatment of lower urinary tract dysfunction after spinal cord injury. J Spinal Cord Med. 2015 Mar;38(2):135-46. doi: 10.1179/2045772314Y.0000000299. Epub 2015 Jan 13.
PubMed 25582564
Groenendijk IM, Groen J, Scheepe JR, Blok BFM. Acute effect of sacral neuromodulation for treatment of detrusor overactivity on urodynamic parameters. Neurourol Urodyn. 2020 Feb;39(2):695-701. doi: 10.1002/nau.24252. Epub 2019 Dec 5.
PubMed 31804759

Interested in taking part?

Jocelyne Bloch, MD

+41 79 556 29 51

jocelyne.bloch@chuv.ch

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
ClinicalTrials.gov ID: NCT06845904
Acronym / sponsor ID: ReeVoid / ReeVoid
Conditions: Spinal Cord Injuries (SCI), Spinal Cord Injury
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 3 participants (estimated)
Lead sponsor: Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
Study start: 10 Mar 2025 (actual)
Primary completion: Feb 2027 (estimated)
Study completion: Feb 2027 (estimated)
First posted: 25 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-site, single-arm, non-blinded, non-randomized, interventional

Arm	Type	Receives
All participants	Experimental	Device: WaveWriter Alpha™ neurostimulation systemAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (22 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WaveWriter Alpha™ neurostimulation systemTwo 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.	Device	All participants

Primary outcome

Occurrence of serious adverse events and adverse events.
Time frame: From enrolment through study completion, an average of 10 months.
Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the use of the investigational.

12 secondary outcomes

ASIA impairment scale - International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
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)
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
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
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
Time frame: Pre-implantation (up to 3 weeks pre-implantation) and upon suspicion
24 hours urine collection
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
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
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)
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
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)
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)
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)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Background: PubMed 8584294Perrouin-Verbe B, Labat JJ, Richard I, Mauduyt de la Greve I, Buzelin JM, Mathe JF. Clean intermittent catheterisation from the acute period in spinal cord injury patients. Long term evaluation of urethral and genital tolerance. Paraplegia. 1995 Nov;33(11):619-24. doi: 10.1038/sc.1995.131.
Background: PubMed 21601270Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR. Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet. 2011 Jun 4;377(9781):1938-47. doi: 10.1016/S0140-6736(11)60547-3. Epub 2011 May 19.
Background: PubMed 29875362Herrity AN, Williams CS, Angeli CA, Harkema SJ, Hubscher CH. Lumbosacral spinal cord epidural stimulation improves voiding function after human spinal cord injury. Sci Rep. 2018 Jun 6;8(1):8688. doi: 10.1038/s41598-018-26602-2.
Background: PubMed 30618826Walter M, Lee AHX, Kavanagh A, Phillips AA, Krassioukov AV. Epidural Spinal Cord Stimulation Acutely Modulates Lower Urinary Tract and Bowel Function Following Spinal Cord Injury: A Case Report. Front Physiol. 2018 Dec 18;9:1816. doi: 10.3389/fphys.2018.01816. eCollection 2018.
Background: PubMed 35132264Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.
Background: PubMed 36343359Jantz MK, Gopinath C, Kumar R, Chin C, Wong L, Ogren JI, Fisher LE, McLaughlin BL, Gaunt RA. High-density spinal cord stimulation selectively activates lower urinary tract nerves. J Neural Eng. 2022 Nov 22;19(6):066014. doi: 10.1088/1741-2552/aca0c2.
Background: PubMed 33505019Squair JW, Gautier M, Mahe L, Soriano JE, Rowald A, Bichat A, Cho N, Anderson MA, James ND, Gandar J, Incognito AV, Schiavone G, Sarafis ZK, Laskaratos A, Bartholdi K, Demesmaeker R, Komi S, Moerman C, Vaseghi B, Scott B, Rosentreter R, Kathe C, Ravier J, McCracken L, Kang X, Vachicouras N, Fallegger F, Jelescu I, Cheng Y, Li Q, Buschman R, Buse N, Denison T, Dukelow S, Charbonneau R, Rigby I, Boyd SK, Millar PJ, Moraud EM, Capogrosso M, Wagner FB, Barraud Q, Bezard E, Lacour SP, Bloch J, Courtine G, Phillips AA. Neuroprosthetic baroreflex controls haemodynamics after spinal cord injury. Nature. 2021 Feb;590(7845):308-314. doi: 10.1038/s41586-020-03180-w. Epub 2021 Jan 27.
Background: PubMed 35292668Soriano JE, Squair JW, Cragg JJ, Thompson J, Sanguinetti R, Vaseghi B, Emery CA, Grant C, Charbonneau R, Larkin-Kaiser KA, Phillips AA, Dujic Z. A national survey of physical activity after spinal cord injury. Sci Rep. 2022 Mar 15;12(1):4405. doi: 10.1038/s41598-022-07927-5.
Background: PubMed 33558526Hoey RF, Medina-Aguinaga D, Khalifa F, Ugiliweneza B, Zdunowski S, Fell J, Naglah A, El-Baz AS, Herrity AN, Harkema SJ, Hubscher CH. Bladder and bowel responses to lumbosacral epidural stimulation in uninjured and transected anesthetized rats. Sci Rep. 2021 Feb 8;11(1):3268. doi: 10.1038/s41598-021-81822-3.
Background: PubMed 35778466Herrity AN, Aslan SC, Mesbah S, Siu R, Kalvakuri K, Ugiliweneza B, Mohamed A, Hubscher CH, Harkema SJ. Targeting bladder function with network-specific epidural stimulation after chronic spinal cord injury. Sci Rep. 2022 Jul 1;12(1):11179. doi: 10.1038/s41598-022-15315-2.
Background: PubMed 30382197Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
Background: PubMed 36352232Kathe C, Skinnider MA, Hutson TH, Regazzi N, Gautier M, Demesmaeker R, Komi S, Ceto S, James ND, Cho N, Baud L, Galan K, Matson KJE, Rowald A, Kim K, Wang R, Minassian K, Prior JO, Asboth L, Barraud Q, Lacour SP, Levine AJ, Wagner F, Bloch J, Squair JW, Courtine G. The neurons that restore walking after paralysis. Nature. 2022 Nov;611(7936):540-547. doi: 10.1038/s41586-022-05385-7. Epub 2022 Nov 9.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jocelyne Bloch, MD contact

+41 79 556 29 51

jocelyne.bloch@chuv.ch

Jocelyne Bloch, MD principal investigator

Centre hospitalier universitaire vaudois (CHUV)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jocelyne Bloch, MD (+41 79 556 29 51, jocelyne.bloch@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of serious adverse events and adverse events. (time frame: From enrolment through study completion, an average of 10 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06845904, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.