Actively Recruiting
The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury
Led by Ankara City Hospital Bilkent · Updated on 2026-05-11
40
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective, randomized clinical trial is to compare the efficacy and safety of transcutaneous sacral magnetic stimulation versus sacral electrical stimulation for detrusor overactivity in 40 male and female patients aged 18-65 with suprasacral Spinal Cord Injury (SCI) whose DOA is confirmed by urodynamics and is refractory to anticholinergic medication. The main question(s) aims to answer : Is there a difference between SMS and SES in their effect on objective urodynamic parameters, such as maximum detrusor pressure during filling and bladder compliance? Is there a difference between SMS and SES in reducing the frequency of incontinence episodes and improving the Neurogenic Bladder Dysfunction Score? Researchers will compare Sacral Magnetic Stimulation and Sacral Electrical Stimulation to see if there are differences in their effects on urodynamic measures, clinical symptoms, and patient satisfaction/discomfort. Participants will: Be randomly assigned to one of two intervention groups: Sacral Magnetic Stimulation or Sacral Electrical Stimulation. Receive 20 sessions of the assigned transcutaneous sacral stimulation technique (5 times a week for 20 minutes per session). Undergo a series of evaluations before and after the 20 treatment sessions, including: Urodynamic assessment (cystometry + EMG). Clinical assessments (3-day bladder diary, Neurogenic Bladder Dysfunction Score, Neurogenic Bowel Dysfunction Score, Spinal Cord Independence Measure - SCIM). Patient-reported outcomes (Treatment Satisfaction Level - Likert Scale, Treatment Discomfort Level - Visual Analog Scale)
CONDITIONS
Official Title
The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-65 years old with traumatic or non-traumatic suprasacral spinal cord injury
- Detrusor overactivity confirmed by urodynamic testing
- Receiving anticholinergic and/or sympathomimetic treatment for at least 3 months with stable doses since last urodynamic exam
You will not qualify if you...
- Presence of a cardiac pacemaker
- Diagnosis of epilepsy
- Metal implant within 10 cm of treatment area
- Botox injection to bladder within last 6 months
- Received any neuromodulation technique in last 6 months
- History of surgical procedures for neurogenic bladder
- Other neurological diseases affecting bladder function (e.g., Parkinson's, polyneuropathy, neurodegenerative disease, cerebrovascular disease)
- Acute urinary tract infection
- Diagnosed bladder outlet obstruction (e.g., urethral stricture, benign prostatic hyperplasia)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
Research Team
Z
Zeynep YAKISIR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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