Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
ConditionSpinal Cord Injuries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShengjing Hospital
About this trial
This clinical trial aims to investigate whether the combination of high-frequency sacral nerve root magnetic stimulation and bladder-directed ultrasound therapy can effectively improve detrusor overactivity (involuntary bladder contractions) and related voiding dysfunctions in patients with spinal cord injury. The main questions it seeks to answer are:
What is the effect of high-frequency sacral nerve root magnetic stimulation on detrusor overactivity and bladder function in patients with spinal cord injury?
What is the effect of bladder-directed ultrasound therapy on detrusor overactivity and bladder wall compliance in patients with spinal cord injury?
Is the combination of these two treatment modalities superior to magnetic stimulation alone?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of spinal cord injury (SCI) above the sacral level according to the International Standards for Neurological Classification of Spinal Cord Injury (revised 2011), confirmed by CT or MRI;
Detrusor overactivity confirmed by urodynamic study;
No severe urinary system diseases such as tumors, stones, infection, or organic urinary tract obstruction;
No severe hepatic/renal insufficiency, pulmonary, or cardiovascular diseases;
Disqualifiers
Unstable vital signs or critically ill condition;
Severe autonomic dysreflexia;
Presence of metallic implants within 10 cm of the magnetic stimulation treatment area;
Any other diseases or conditions that may interfere with the study outcomes.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
DeviceParticipants receive the intervention assigned to their group 7 days per week for 3 weeks.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Experimental Group: Sacral Nerve Root Magnetic Stimulation + Active Ultrasound TherapyExperimental treatment 1 intervention
Group B: Control Group： Sacral Nerve Root Magnetic Stimulation + Sham Ultrasound TherapySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bladder capacity at first detrusor overactivity
Measured by urodynamic study. The volume at which involuntary detrusor contraction first occurs during bladder filling. Target safe capacity ≥300 ml.
Time frame
Baseline and immediately after 3-week interventionSecondary outcomes
1
Urodynamic parameters-Bladder compliance
reflecting bladder wall elasticity, calculated as the change in bladder volume divided by the change in detrusor pressure, ΔV/ΔP
Time frame
Baseline and immediately after 3-week intervention2
Chinese version of the Neurogenic Bladder (NB) Brief Health Survey
assessing the impact of neurogenic bladder on overall health status and daily living
Time frame
Baseline and immediately after 3-week intervention3
Voiding diary parameters
Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours.
Time frame
Baseline and after 3-week intervention4
Urodynamic parameters-First sensation of bladder filling
the infused volume at which the subject first perceives the initial urge to void
Time frame
Baseline and immediately after 3-week interventionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: