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Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

9. Juli 2026 aktualisiert von: 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?

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

44

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
Schein-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.
Gerät: Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bladder capacity at first detrusor overactivity
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Urodynamic parameters-Bladder compliance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shengjing Hospital

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Juli 2026

Primärer Abschluss (Geschätzt)

30. April 2027

Studienabschluss (Geschätzt)

30. April 2027

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juli 2026

Zuerst gepostet (Tatsächlich)

15. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026PS1147K

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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