Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
9 lipca 2026 zaktualizowane przez: 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?
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Szacowany)
44
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Xue Jiang
- Numer telefonu: +86 18940254064
- E-mail: jiangxueruby@163.com
Kopia zapasowa kontaktu do badania
- Nazwa: Kaixuan Zhu
- Numer telefonu: 17860690831
- E-mail: 2033055053@qq.com
Lokalizacje studiów
-
-
-
Shenyang, Chiny
- Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
-
Kontakt:
- Xue Jiang
- Numer telefonu: +86 189 4025 4064
- E-mail: jiangxueruby@163.com
-
Kontakt:
- Kaixuan Zhu
- Numer telefonu: +8617860690831
- E-mail: 2033055053@qq.com
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Pozorny 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.
|
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Bladder capacity at first detrusor overactivity
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Urodynamic parameters-Bladder compliance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
10 lipca 2026
Zakończenie podstawowe (Szacowany)
30 kwietnia 2027
Ukończenie studiów (Szacowany)
30 kwietnia 2027
Daty rejestracji na studia
Pierwszy przesłany
6 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 lipca 2026
Pierwszy wysłany (Rzeczywisty)
15 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026PS1147K
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .