Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
9. července 2026 aktualizováno: 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?
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
44
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Xue Jiang
- Telefonní číslo: +86 18940254064
- E-mail: jiangxueruby@163.com
Studijní záloha kontaktů
- Jméno: Kaixuan Zhu
- Telefonní číslo: 17860690831
- E-mail: 2033055053@qq.com
Studijní místa
-
-
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Shenyang, Čína
- Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
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Kontakt:
- Xue Jiang
- Telefonní číslo: +86 189 4025 4064
- E-mail: jiangxueruby@163.com
-
Kontakt:
- Kaixuan Zhu
- Telefonní číslo: +8617860690831
- E-mail: 2033055053@qq.com
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
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|
Falešný srovnávač: 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.
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Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bladder capacity at first detrusor overactivity
Časové okno: 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.
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Baseline and immediately after 3-week intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Urodynamic parameters-Bladder compliance
Časové okno: 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
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Baseline and immediately after 3-week intervention
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Chinese version of the Neurogenic Bladder (NB) Brief Health Survey
Časové okno: Baseline and immediately after 3-week intervention
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assessing the impact of neurogenic bladder on overall health status and daily living
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Baseline and immediately after 3-week intervention
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Voiding diary parameters
Časové okno: Baseline and after 3-week intervention
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Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours.
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Baseline and after 3-week intervention
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Urodynamic parameters-First sensation of bladder filling
Časové okno: Baseline and immediately after 3-week intervention
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the infused volume at which the subject first perceives the initial urge to void
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Baseline and immediately after 3-week intervention
|
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Infection-related indicators-Urine white blood cell (WBC) count
Časové okno: Baseline and immediately after 3-week intervention
|
an objective laboratory quantitative indicator of urinary tract infection
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Baseline and immediately after 3-week intervention
|
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Antibiotic utilization rate
Časové okno: 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
|
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Urodynamic parameters-Detrusor leak point pressure
Časové okno: Baseline and immediately after 3-week intervention
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the detrusor pressure at the moment of urinary leakage during storage, reflecting urethral closure reserve
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Baseline and immediately after 3-week intervention
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Urodynamic parameters-Maximum detrusor contraction pressure
Časové okno: Baseline and immediately after 3-week intervention
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the peak detrusor pressure achieved during the voiding phase
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Baseline and immediately after 3-week intervention
|
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Urodynamic parameters-Duration of detrusor contraction
Časové okno: Baseline and immediately after 3-week intervention
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the total time of sustained effective detrusor contraction during voiding
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Baseline and immediately after 3-week intervention
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Overactive Bladder Symptom Score (OABSS)
Časové okno: Baseline and immediately after 3-week intervention
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quantifying the severity of lower urinary tract symptoms including frequency, urgency, and urgency incontinence
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Baseline and immediately after 3-week intervention
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Voiding difficulty score
Časové okno: Baseline and immediately after 3-week intervention
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assessing subjective symptoms such as straining, weak stream, and hesitancy
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Baseline and immediately after 3-week intervention
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Quality of Life score (QoL)
Časové okno: Baseline and immediately after 3-week intervention
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evaluating the interference of lower urinary tract dysfunction with daily activities, social functioning, and emotional well-being
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Baseline and immediately after 3-week intervention
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Bladder wall thickness
Časové okno: Baseline and immediately after 3-week intervention
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measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes
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Baseline and immediately after 3-week intervention
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Bladder tissue architecture / morphology
Časové okno: Baseline and immediately after 3-week intervention
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including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity
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Baseline and immediately after 3-week intervention
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Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis
Časové okno: Baseline and immediately after 3-week intervention
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comprehensively assessing the degree of ureteral and pelvicalyceal dilatation as structural indicators of upper urinary tract damage risk
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Baseline and immediately after 3-week intervention
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
10. července 2026
Primární dokončení (Odhadovaný)
30. dubna 2027
Dokončení studie (Odhadovaný)
30. dubna 2027
Termíny zápisu do studia
První předloženo
6. července 2026
První předloženo, které splnilo kritéria kontroly kvality
9. července 2026
První zveřejněno (Aktuální)
15. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. července 2026
Naposledy ověřeno
1. července 2026
Více informací
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