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

NCT06845904 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

DEVICE

WaveWriter Alpha™ neurostimulation system

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.

Sponsors & Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

    lead OTHER

Principal Investigators

  • Jocelyne Bloch, MD · Centre hospitalier universitaire vaudois (CHUV)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06845904 on ClinicalTrials.gov