RecruitingNot ApplicableNCT07578532

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

Sponsor

Ankara City Hospital Bilkent

Enrollment

40 participants

Start Date

Mar 26, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries (SCI)detrusor overactivity

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

-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 Criteria9

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.

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Interventions

DEVICETranscutaneous Sacral Electrical Stimulation

Electrical stimulation will be applied symmetrically to both sides on the level determined to be over the S3 foramina by manual palpation of the sacrum, using 5x5 cm electrodes, and the current intensity will be increased until contraction is observed in the patient's external anal sphincter, at a current frequency of 20 Hz, pulse duration of 200 microseconds, 5 times a week for 20 minutes for 20 sessions.

DEVICETranscutaneous sacral magnetic stimulation

The group to receive magnetic stimulation will be given a total of 1200 shots for 2 seconds with 28-second intervals, at a frequency of 10 Hz for 20 minutes, 5 times a week for 20 sessions, creating a feeling of contraction in the inner thigh or perineum, using the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device available at our hospital. For repetitive magnetic stimulation of the sacral roots, the patients will be placed in the prone position, and 8 coils with an outer diameter of 70 mm will be positioned on the midline of the sacrum to cover the bilateral third sacral neural foramina.