Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
9 de julio de 2026 actualizado por: Xue Jiang, Shengjing Hospital
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
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?
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xue Jiang
- Número de teléfono: +86 18940254064
- Correo electrónico: jiangxueruby@163.com
Copia de seguridad de contactos de estudio
- Nombre: Kaixuan Zhu
- Número de teléfono: 17860690831
- Correo electrónico: 2033055053@qq.com
Ubicaciones de estudio
-
-
-
Shenyang, Porcelana
- Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
-
Contacto:
- Xue Jiang
- Número de teléfono: +86 189 4025 4064
- Correo electrónico: jiangxueruby@163.com
-
Contacto:
- Kaixuan Zhu
- Número de teléfono: +8617860690831
- Correo electrónico: 2033055053@qq.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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;
- Aged 18-80 years;
- Able to understand and comply with the required examinations, rehabilitation assessments, and treatment, and provide written informed consent.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
|
|
Comparador falso: 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.
|
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bladder capacity at first detrusor overactivity
Periodo de tiempo: 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.
|
Baseline and immediately after 3-week intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Urodynamic parameters-Bladder compliance
Periodo de tiempo: 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
|
Baseline and immediately after 3-week intervention
|
|
Chinese version of the Neurogenic Bladder (NB) Brief Health Survey
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
assessing the impact of neurogenic bladder on overall health status and daily living
|
Baseline and immediately after 3-week intervention
|
|
Voiding diary parameters
Periodo de tiempo: Baseline and after 3-week intervention
|
Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours.
|
Baseline and after 3-week intervention
|
|
Urodynamic parameters-First sensation of bladder filling
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
the infused volume at which the subject first perceives the initial urge to void
|
Baseline and immediately after 3-week intervention
|
|
Infection-related indicators-Urine white blood cell (WBC) count
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
an objective laboratory quantitative indicator of urinary tract infection
|
Baseline and immediately after 3-week intervention
|
|
Antibiotic utilization rate
Periodo de tiempo: 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
|
Baseline and immediately after 3-week intervention
|
|
Urodynamic parameters-Detrusor leak point pressure
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
the detrusor pressure at the moment of urinary leakage during storage, reflecting urethral closure reserve
|
Baseline and immediately after 3-week intervention
|
|
Urodynamic parameters-Maximum detrusor contraction pressure
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
the peak detrusor pressure achieved during the voiding phase
|
Baseline and immediately after 3-week intervention
|
|
Urodynamic parameters-Duration of detrusor contraction
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
the total time of sustained effective detrusor contraction during voiding
|
Baseline and immediately after 3-week intervention
|
|
Overactive Bladder Symptom Score (OABSS)
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
quantifying the severity of lower urinary tract symptoms including frequency, urgency, and urgency incontinence
|
Baseline and immediately after 3-week intervention
|
|
Voiding difficulty score
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
assessing subjective symptoms such as straining, weak stream, and hesitancy
|
Baseline and immediately after 3-week intervention
|
|
Quality of Life score (QoL)
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
evaluating the interference of lower urinary tract dysfunction with daily activities, social functioning, and emotional well-being
|
Baseline and immediately after 3-week intervention
|
|
Bladder wall thickness
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes
|
Baseline and immediately after 3-week intervention
|
|
Bladder tissue architecture / morphology
Periodo de tiempo: Baseline and immediately after 3-week intervention
|
including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity
|
Baseline and immediately after 3-week intervention
|
|
Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis
Periodo de tiempo: 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
|
Baseline and immediately after 3-week intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de julio de 2026
Finalización primaria (Estimado)
30 de abril de 2027
Finalización del estudio (Estimado)
30 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026PS1147K
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .