Transcutaneous sacral magnetic versus electrical stimulation for overactive bladder after spinal cord injury
The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury
This trial will try two noninvasive sacral stimulation methods—magnetic and electrical—to see which better reduces bladder overactivity in adults (18–65) with suprasacral spinal cord injury who still have symptoms despite anticholinergic drugs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07578532 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized trial enrolling 40 adults with suprasacral spinal cord injury and urodynamically confirmed detrusor overactivity that is refractory to stable anticholinergic treatment. Participants are randomly assigned to receive either transcutaneous sacral magnetic stimulation (SMS) or transcutaneous sacral electrical stimulation (SES). Investigators will compare objective urodynamic measures (including maximum detrusor pressure during filling and bladder compliance), frequency of incontinence episodes, Neurogenic Bladder Dysfunction Score, and patient-reported discomfort/satisfaction. Safety and tolerability of both noninvasive stimulation approaches will also be recorded.
Who should consider this trial
Good fit: Adults aged 18–65 with traumatic or nontraumatic suprasacral spinal cord injury, urodynamically confirmed detrusor overactivity, and stable anticholinergic/sympathomimetic treatment for at least 3 months are ideal candidates.
Not a fit: Patients with cardiac pacemakers, epilepsy, metal implants near the treatment site, recent bladder botulinum toxin or neuromodulation within 6 months, prior neurogenic bladder surgery, or other neurological diseases affecting bladder function are excluded and unlikely to benefit from these interventions in this trial.
Why it matters
Potential benefit: If successful, one of these noninvasive stimulation methods could lower bladder pressures, reduce incontinence, and improve quality of life while avoiding or reducing reliance on medications or invasive procedures.
How similar studies have performed: Previous small studies and clinical experience with sacral electrical and magnetic stimulation show potential benefit for neurogenic detrusor overactivity, but direct randomized head-to-head comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Ankara
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Zuhal Özişler — Ankara City Hospital Bilkent
- Study coordinator: Zeynep YAKISIR
- Email: zeynepyaksr@yahoo.com
- Phone: +905347278666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.