Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
Shenyang, China
Location contact
Kaixuan Zhu
CONTACT
Xue Jiang
CONTACT
NCT Number: NCT07704268
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?
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Shenyang, China
Kaixuan Zhu
CONTACT
Xue Jiang
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive the intervention assigned to their group 7 days per week for 3 weeks.
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.
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
Time frame: Baseline and immediately after 3-week intervention
assessing the impact of neurogenic bladder on overall health status and daily living
Time frame: Baseline and after 3-week intervention
Includes single-void volume, urgency score, and incontinence episodes, recorded over at least 72 consecutive hours.
Time frame: Baseline and immediately after 3-week intervention
the infused volume at which the subject first perceives the initial urge to void
Time frame: Baseline and immediately after 3-week intervention
an objective laboratory quantitative indicator of urinary tract infection
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
Time frame: Baseline and immediately after 3-week intervention
the detrusor pressure at the moment of urinary leakage during storage, reflecting urethral closure reserve
Time frame: Baseline and immediately after 3-week intervention
the peak detrusor pressure achieved during the voiding phase
Time frame: Baseline and immediately after 3-week intervention
the total time of sustained effective detrusor contraction during voiding
Time frame: Baseline and immediately after 3-week intervention
quantifying the severity of lower urinary tract symptoms including frequency, urgency, and urgency incontinence
Time frame: Baseline and immediately after 3-week intervention
assessing subjective symptoms such as straining, weak stream, and hesitancy
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
Time frame: Baseline and immediately after 3-week intervention
measured by ultrasound, reflecting detrusor hypertrophy or fibrotic changes
Time frame: Baseline and immediately after 3-week intervention
including wall layering clarity, mucosal surface regularity, and internal echogenicity uniformity
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
Contact information is provided by the study sponsor or research team.
Kaixuan Zhu
CONTACT
Xue Jiang
CONTACT
Shengjing Hospital
Other
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
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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