Transcutaneous sacral magnetic versus electrical stimulation for overactive bladder after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.