Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
2026년 7월 9일 업데이트: 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?
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
44
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xue Jiang
- 전화번호: +86 18940254064
- 이메일: jiangxueruby@163.com
연구 연락처 백업
- 이름: Kaixuan Zhu
- 전화번호: 17860690831
- 이메일: 2033055053@qq.com
연구 장소
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Shenyang, 중국
- Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
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연락하다:
- Xue Jiang
- 전화번호: +86 189 4025 4064
- 이메일: jiangxueruby@163.com
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연락하다:
- Kaixuan Zhu
- 전화번호: +8617860690831
- 이메일: 2033055053@qq.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
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가짜 비교기: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bladder capacity at first detrusor overactivity
기간: Baseline and immediately after 3-week intervention
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Urodynamic parameters-Bladder compliance
기간: Baseline and immediately after 3-week intervention
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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
기간: 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
기간: 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
기간: 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
기간: Baseline and immediately after 3-week intervention
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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
기간: Baseline and immediately after 3-week intervention
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calculated as defined daily doses per treatment cycle, reflecting the frequency of antibiotic intervention due to infection during the treatment period
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Baseline and immediately after 3-week intervention
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Urodynamic parameters-Detrusor leak point pressure
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 10일
기본 완료 (추정된)
2027년 4월 30일
연구 완료 (추정된)
2027년 4월 30일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 9일
처음 게시됨 (실제)
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 9일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .