The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injuries (SCI), Detrusor Overactivity

In brief

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)

Key facts

Study ID

NCT07578532

Run by

Ankara City Hospital Bilkent

People needed

40

Starts

2025-03-26

Expected to finish

2026-09-26

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with a cardiac pacemaker,
• Patients diagnosed with epilepsy,
• 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 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.

Where it is running

• Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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