Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

9. juli 2026 opdateret af: 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?

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
Sham-komparator: 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.
Enhed: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bladder capacity at first detrusor overactivity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urodynamic parameters-Bladder compliance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shengjing Hospital

Efterforskere

  • Ledende efterforsker: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juli 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. april 2027

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026PS1147K

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner