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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Zeynep YAKISIR
zeynepyaksr@yahoo.com
+905347278666
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2026-09-26
Participants
Target number of participants: 40
Treatments
Active_comparator: Transcutaneous sacral electrical stimulation
Suprasacral spinal cord injury patients receiving transcutaneous sacral electrical stimulation
Active_comparator: Transcutaneous sacral magnetic stimulation
Suprasacral spinal cord injury patients receiving transcutaneous sacral magnetic stimulation
Sponsors
Leads: Ankara City Hospital Bilkent

This content was sourced from clinicaltrials.gov