Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
Spinal Cord Injuries
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 80 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 44 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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?
Leer la descripción completa
Researchers will combine high-frequency sacral nerve root magnetic stimulation with bladder ultrasound therapy and compare this combination against magnetic stimulation alone (with sham ultrasound) to determine whether the combined approach provides added benefit.
Participants will:
Receive either sacral nerve root magnetic stimulation, bladder ultrasound therapy, or the combination of both, once daily for 3 consecutive weeks (7 sessions per week).
Attend the hospital for urodynamic testing (to assess safe bladder capacity, storage pressure, and compliance) and urinary tract ultrasound (to evaluate bladder wall thickness and upper urinary tract structure) before the treatment and after the 3-week intervention.
Maintain a voiding diary for at least 3 consecutive days (recording single voided volumes, urgency scores, and incontinence episodes), and complete validated questionnaires on lower urinary tract symptoms and quality of life.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. 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;
2. Detrusor overactivity confirmed by urodynamic study;
3. No severe urinary system diseases such as tumors, stones, infection, or organic urinary tract obstruction;
4. No severe hepatic/renal insufficiency, pulmonary, or cardiovascular diseases;
5. Aged 18-80 years;
6. Able to understand and comply with the required examinations, rehabilitation assessments, and treatment, and provide written informed consent.
Exclusion Criteria:
1. Unstable vital signs or critically ill condition;
2. Severe autonomic dysreflexia;
3. Presence of metallic implants within 10 cm of the magnetic stimulation treatment area;
4. Any other diseases or conditions that may interfere with the study outcomes.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Experimental Group: Sacral Nerve Root Magnetic Stimulation + Active Ultrasound Therapy
Magnetic stimulation: round coil over S3 foramina, verified by toe twitch. 20 Hz intermittent, 1000 pulses/session, intensity 55%-100% max. Active ultrasound: after saline infusion with pressure monitoring (stop at 40 cmH₂O or discomfort), 1.0 MHz, 1.5-2.0 W/cm², 1000 μs PRP, 1:4 duty cycle, 200 μs pulse duration. Probe moved over suprapubic area, 20 min/session. Both given once daily, 7 days/week for 3 weeks. Stop immediately if pressure \>40 cmH₂O or any discomfort.
Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Control Group： Sacral Nerve Root Magnetic Stimulation + Sham Ultrasound Therapy
Magnetic stimulation: identical to Arm 1. Sham ultrasound: same probe, same interface settings (frequency, intensity display, pulse parameters) but zero output power. Bladder infusion and pressure monitoring same as Arm 1. Probe moved over suprapubic area for 20 min/session. Treatment frequency and duration identical to Arm 1 (once daily, 7 days/week, 3 weeks). Stop if pressure \>40 cmH₂O or discomfort.
Device: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device DEVICE
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Bladder capacity at first detrusor overactivity
Plazo: Baseline and immediately after 3-week intervention
Measured by urodynamic study. The volume at which involuntary detrusor contraction first occurs during bladder filling. Target safe capacity ≥300 ml.
Medidas secundarias
Urodynamic parameters-Bladder compliance
Plazo: Baseline and immediately after 3-week intervention
reflecting bladder wall elasticity, calculated as the change in bladder volume divided by the change in detrusor pressure, ΔV/ΔP
Chinese version of the Neurogenic Bladder (NB) Brief Health Survey
Plazo: Baseline and immediately after 3-week intervention
assessing the impact of neurogenic bladder on overall health status and daily living
Voiding diary parameters
Plazo: Baseline and after 3-week intervention
Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours.
Urodynamic parameters-First sensation of bladder filling
Plazo: Baseline and immediately after 3-week intervention
the infused volume at which the subject first perceives the initial urge to void
Infection-related indicators-Urine white blood cell (WBC) count
Plazo: Baseline and immediately after 3-week intervention
an objective laboratory quantitative indicator of urinary tract infection
Antibiotic utilization rate
Plazo: Baseline and immediately after 3-week intervention
calculated as defined daily doses per treatment cycle, reflecting the frequency of antibiotic intervention due to infection during the treatment period
Urodynamic parameters-Detrusor leak point pressure
Plazo: Baseline and immediately after 3-week intervention
the detrusor pressure at the moment of urinary leakage during storage, reflecting urethral closure reserve
Urodynamic parameters-Maximum detrusor contraction pressure
Plazo: Baseline and immediately after 3-week intervention
the peak detrusor pressure achieved during the voiding phase
Urodynamic parameters-Duration of detrusor contraction
Plazo: Baseline and immediately after 3-week intervention
the total time of sustained effective detrusor contraction during voiding
Overactive Bladder Symptom Score (OABSS)
Plazo: Baseline and immediately after 3-week intervention
quantifying the severity of lower urinary tract symptoms including frequency, urgency, and urgency incontinence
Voiding difficulty score
Plazo: Baseline and immediately after 3-week intervention
assessing subjective symptoms such as straining, weak stream, and hesitancy
Quality of Life score (QoL)
Plazo: Baseline and immediately after 3-week intervention
evaluating the interference of lower urinary tract dysfunction with daily activities, social functioning, and emotional well-being
Bladder wall thickness
Plazo: Baseline and immediately after 3-week intervention
measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes
Bladder tissue architecture / morphology
Plazo: Baseline and immediately after 3-week intervention
including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity
Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis
Plazo: Baseline and immediately after 3-week intervention
comprehensively assessing the degree of ureteral and pelvicalyceal dilatation as structural indicators of upper urinary tract damage risk
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000Shenyang, ChinaReclutando
Equipo y fechas
- Patrocinador principal
- Shengjing Hospital
- Inicio del estudio
- 1 jul 2026 Real
- Finalización primaria
- 30 abr 2027 Estimado
- Finalización del estudio
- 30 abr 2027 Estimado
- Primera publicación
- 15 jul 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Randomized, Double-Blind, Sham-Controlled Trial of Sacral Nerve Root High-Frequency Magnetic Stimulation Combined With Ultrasound Therapy for Detrusor Overactivity in Patients With Spinal Cord Injury
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026