NCT07578532 The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury
| NCT ID | NCT07578532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara City Hospital Bilkent |
| Condition | Spinal Cord Injuries (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-09-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-03-26 with a primary completion date of 2026-09-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility 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.
Contact & Investigator
Zuhal Özişler
PRINCIPAL INVESTIGATOR
Ankara City Hospital Bilkent
Frequently Asked Questions
Who can join the NCT07578532 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Spinal Cord Injuries (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07578532 currently recruiting?
Yes, NCT07578532 is actively recruiting participants. Contact the research team at zeynepyaksr@yahoo.com for enrollment information.
Where is the NCT07578532 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07578532 clinical trial?
NCT07578532 is sponsored by Ankara City Hospital Bilkent. The principal investigator is Zuhal Özişler at Ankara City Hospital Bilkent. The trial plans to enroll 40 participants.