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

NCT06845904 | Recruiting DMC

• 1 other identifier: ReeVoid
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries (SCI); Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  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

  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

  Pre-implantation (up to 3 weeks pre-implantation) and upon suspicion

Other Outcomes (5)

• NBDS (Neurogenic Bowel Dysfunction Score)

  Pre-implantation (up to 2 weeks pre-implantation) and monthly for 9 months post-implantation

• NBSS (Neurogenic Bladder Symptom Score)

  Pre-implantation (up to 2 weeks pre-implantation) and monthly for 9 months post-implantation

• SF-Qualiveen (QUALIVEEN Short Form)

  Pre-implantation (up to 2 weeks pre-implantation) and monthly for 9 months post-implantation

Study Arms (1)

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.

Device: WaveWriter Alpha™ neurostimulation system

Interventions

WaveWriter Alpha™ neurostimulation system DEVICE

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.

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (20)

• 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.

  PMID: 8584294 BACKGROUND

• 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.

  PMID: 21601270 BACKGROUND

• 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.

  PMID: 29875362 BACKGROUND

• 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.

  PMID: 30618826 BACKGROUND

• 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.

  PMID: 35132264 BACKGROUND

• 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.

  PMID: 36343359 BACKGROUND

• 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.

  PMID: 33505019 BACKGROUND

• 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.

  PMID: 35292668 BACKGROUND

• 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.

  PMID: 33558526 BACKGROUND

• 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.

  PMID: 35778466 BACKGROUND

• 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.

  PMID: 30382197 BACKGROUND

• 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.

  PMID: 36352232 BACKGROUND

• 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.

  PMID: 36396975 BACKGROUND

• 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.

  PMID: 25582564 BACKGROUND

• 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.

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• Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013.

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• Squair JW, Dhaliwal R, Cragg JJ, Charbonneau R, Grant C, Phillips AA. National Survey of Bladder and Gastrointestinal Dysfunction in People with Spinal Cord Injury. J Neurotrauma. 2019 Jun 15;36(12):2011-2019. doi: 10.1089/neu.2018.5967. Epub 2019 Jan 25.

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• Panicker JN, Fowler CJ, Kessler TM. Lower urinary tract dysfunction in the neurological patient: clinical assessment and management. Lancet Neurol. 2015 Jul;14(7):720-32. doi: 10.1016/S1474-4422(15)00070-8.

  PMID: 26067125 BACKGROUND

• Hou S, Rabchevsky AG. Autonomic consequences of spinal cord injury. Compr Physiol. 2014 Oct;4(4):1419-53. doi: 10.1002/cphy.c130045.

  PMID: 25428850 BACKGROUND

• Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. doi: 10.1089/neu.2004.21.1355.

  PMID: 15672627 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jocelyne Bloch, MD

  Centre hospitalier universitaire vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyne Bloch, MD

CONTACT

+41 79 556 29 51; jocelyne.bloch@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Single-site, single-arm, non-blinded, non-randomized, interventional

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 25, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)