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NCT Number: NCT07704268

Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI

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?

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation (TMS) Device /Ultrasound therapy device

Device

Participants receive the intervention assigned to their group 7 days per week for 3 weeks.

Primary outcomes

  1. Bladder capacity at first detrusor overactivity

    Time frame: 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.

Secondary outcomes

  1. Urodynamic parameters-Bladder compliance

    Time frame: 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

  2. Chinese version of the Neurogenic Bladder (NB) Brief Health Survey

    Time frame: Baseline and immediately after 3-week intervention

    assessing the impact of neurogenic bladder on overall health status and daily living

  3. Voiding diary parameters

    Time frame: Baseline and after 3-week intervention

    Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours.

  4. Urodynamic parameters-First sensation of bladder filling

    Time frame: Baseline and immediately after 3-week intervention

    the infused volume at which the subject first perceives the initial urge to void

  5. Infection-related indicators-Urine white blood cell (WBC) count

    Time frame: Baseline and immediately after 3-week intervention

    an objective laboratory quantitative indicator of urinary tract infection

  6. Antibiotic utilization rate

    Time frame: 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

  7. Urodynamic parameters-Detrusor leak point pressure

    Time frame: Baseline and immediately after 3-week intervention

    the detrusor pressure at the moment of urinary leakage during storage, reflecting urethral closure reserve

  8. Urodynamic parameters-Maximum detrusor contraction pressure

    Time frame: Baseline and immediately after 3-week intervention

    the peak detrusor pressure achieved during the voiding phase

  9. Urodynamic parameters-Duration of detrusor contraction

    Time frame: Baseline and immediately after 3-week intervention

    the total time of sustained effective detrusor contraction during voiding

  10. Overactive Bladder Symptom Score (OABSS)

    Time frame: Baseline and immediately after 3-week intervention

    quantifying the severity of lower urinary tract symptoms including frequency, urgency, and urgency incontinence

  11. Voiding difficulty score

    Time frame: Baseline and immediately after 3-week intervention

    assessing subjective symptoms such as straining, weak stream, and hesitancy

  12. Quality of Life score (QoL)

    Time frame: Baseline and immediately after 3-week intervention

    evaluating the interference of lower urinary tract dysfunction with daily activities, social functioning, and emotional well-being

  13. Bladder wall thickness

    Time frame: Baseline and immediately after 3-week intervention

    measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes

  14. Bladder tissue architecture / morphology

    Time frame: Baseline and immediately after 3-week intervention

    including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity

  15. Upper urinary tract dilation, pelvicalyceal system separation, and hydronephrosis

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kaixuan Zhu

CONTACT

[email protected]

17860690831

Xue Jiang

CONTACT

[email protected]

+86 18940254064

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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