Actively Recruiting
Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-07-14
3
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent before any study procedures
- Spinal cord injury lesion level at or above T11
- SCI classified as AIS-B, AIS-C, or AIS-D
- Spinal cord injury occurred 6 months or more ago
- Confirmed lower urinary tract dysfunction by urodynamic testing (NDO, DSD)
- Intolerant, resistant, or not responding well to medications and behavioral treatments
- Currently using intermittent self-catheterization
- Medically, physically, and psychologically stable as judged by investigators
- Able to communicate and interact with study staff in French or English
- Willing to comply with study conditions and attend all visits
You will not qualify if you...
- Received botulinum toxin bladder injections in the last 6 months
- Receiving other non-drug treatments for bladder dysfunction (e.g., sacral nerve stimulation)
- Having or needing a suprapubic or indwelling bladder catheter
- Presence of upper urinary tract dilation or bladder/renal stones
- Urethral stricture or significant benign prostate enlargement
- Significant pressure ulcers
- Previous lower urinary tract surgery
- Autonomic dysreflexia during urodynamic testing
- Recurrent symptomatic urinary tract infections (more than 3 per year)
- Presence of intrathecal baclofen pump
- Medical conditions increasing risks of spinal surgery
- Other serious diseases (e.g., syringomyelia, bladder cancer, renal failure, liver problems, heart disease)
- Unable to stop antiplatelet or anticoagulant medications around surgery
- Presence of cardiac pacemakers
- Other conditions preventing participation per investigator judgment
- Pregnant or breastfeeding women
- Lack of reliable contraception for women of childbearing potential
- Planning pregnancy during study
- Unable to follow study procedures due to language, mental, or psychological issues
- Participation in another trial with investigational drug or device within 30 days before or during study
- Any indication requiring MRI
- Investigator or close relations/employees involved in study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
J
Jocelyne Bloch, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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