Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI
2026年7月9日 更新者：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?
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
44
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xue Jiang
- 電話番号：+86 18940254064
- メール：jiangxueruby@163.com
研究連絡先のバックアップ
- 名前：Kaixuan Zhu
- 電話番号：17860690831
- メール：2033055053@qq.com
研究場所
-
-
-
Shenyang、中国
- Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
-
コンタクト：
- Xue Jiang
- 電話番号：+86 189 4025 4064
- メール：jiangxueruby@163.com
-
コンタクト：
- Kaixuan Zhu
- 電話番号：+8617860690831
- メール：2033055053@qq.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
偽コンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bladder capacity at first detrusor overactivity
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Urodynamic parameters-Bladder compliance
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Xue Jiang、Rehabilitation Center of Shengjing Hospital, China Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月10日
一次修了 (推定)
2027年4月30日
研究の完了 (推定)
2027年4月30日
試験登録日
最初に提出
2026年7月6日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月9日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。