The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Ankara, TürkiyeSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 26 Mar 2025
- Planned end
- 26 Sept 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Transcutaneous Sacral Electrical Stimulation
- Transcutaneous sacral magnetic stimulation
- Record updated
- 11 May 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 18-65 years old Traumatic and non-traumatic suprasacral SCI; Detrusor overactivity confirmed by urodynamics (spontaneous and/or provocative detrusor contraction during the filling phase will be accepted as detrusor overactivity) Patients who have been receiving anticholinergic and/or sympathomimetic treatment for the last 3 months and whose pharmacological medical treatment dose has not been changed since the last urodynamic examination will be included in the study
Who cannot take part
- Patients with a metal implant within a 10 cm radius of the area where the treatment will be applied,
- Patients who have received botox injection to the bladder in the last 6 months,
- Patients who have received any neuromodulation technique in the last 6 months,
- Patients who have undergone surgical procedure for neurogenic bladder,
- Patients with a cardiac pacemaker,
- Patients diagnosed with epilepsy,
- Patients with another neurological disease that may affect neurogenic bladder (Parkinson's, polyneuropathy, neurodegenerative disease, cerebrovascular disease, etc.)
- Patients with acute urinary tract infection,
- Patients diagnosed with bladder outlet obstruction (urethral stricture, benign prostatic hyperplasia, etc.) will not be included in the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Türkiye
- Ankara Bilkent City HospitalAnkara, TürkiyeContact: Zeynep YAKISIRTaking people
About the trial
What the trial wants to find out
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 :
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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)
The 2 groups in the trial
- Transcutaneous sacral electrical stimulationExisting treatment, for comparison
Suprasacral spinal cord injury patients receiving transcutaneous sacral electrical stimulation
- Transcutaneous sacral magnetic stimulationExisting treatment, for comparison
Suprasacral spinal cord injury patients receiving transcutaneous sacral magnetic stimulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07578532, who can take part
- Record updated
- 11 May 2026