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Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

9 de julho de 2026 atualizado 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?

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

44

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
      • Shenyang, China
        • Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Dispositivo: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
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.
Dispositivo: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Bladder capacity at first detrusor overactivity
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Urodynamic parameters-Bladder compliance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shengjing Hospital

Investigadores

  • Investigador principal: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

10 de julho de 2026

Conclusão Primária (Estimado)

30 de abril de 2027

Conclusão do estudo (Estimado)

30 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2026

Primeira postagem (Real)

15 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026PS1147K

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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