Actively Recruiting
Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children
Led by Shanghai Children's Medical Center · Updated on 2025-06-05
200
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Urine storage and voiding are fundamental physiological processes. In clinical settings, many cases of lower urinary tract dysfunction (LUTD) are closely associated with abnormal conditioned reflexes formed in the central nervous system during the urine storage or voiding phases. Relaxation, as a core physiological and psychological state, has been shown to promote effective urine storage and facilitate smooth voiding. By repeatedly training individuals to establish a new conditioned reflex linking the sensation of urinary urgency with a state of relaxation, it may be possible to improve bladder storage capacity and voiding function. Based on this concept, the investigators have developed the world's first Micturition Desire-Relaxation Training Device (Chinese Patent No.: ZL 2020 1 0397789.4). This study aims to evaluate the clinical efficacy of this device in treating LUTD in children.
CONDITIONS
Official Title
Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of nocturnal enuresis with at least one episode of involuntary nighttime urination per month for over 3 months
- No abnormalities in routine urinalysis and no bedwetting-free periods longer than 6 months unless due to organic disease
- Diagnosis of daytime urinary incontinence with at least one episode of intermittent urinary leakage during wakefulness per month for over 3 months
- No anatomical or neurological causes of urinary incontinence
- Diagnosis of urinary frequency involving frequent small volume urination during day and before sleep, with normal total daily urine volume
- Age between 5 and 18 years, any gender
- Voluntary participation with informed consent signed by child and guardian
You will not qualify if you...
- Enuresis caused by urinary tract infections, pinworms, myelitis, spinal cord injuries, epilepsy, cerebral developmental disorders, diabetes, or other neurological, urinary, or endocrine diseases
- Transient enuresis due to excessive activity, mental fatigue, or excessive fluid intake before bedtime
- Urinary frequency caused by neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases
- Participation in other clinical trials within the past month
- Any condition deemed unsuitable for trial participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Micturition Desire-Relaxation Training
Shanghai, Shanghai Municipality, China, 200122
Actively Recruiting
Research Team
J
jun ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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