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Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children

Study acronym: ICCS,LUTD,PNE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 5, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Secondary endpoints: details revised at 2 of 8 entries
    • Study description shortened, about 59 words
    • Publications: details revised at 2 of 2 entries
    • Study title expanded, about 3 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07000656
Lead Sponsor Shanghai Children's Medical Center
Conditions
(from sponsor)
Daytime Urinary Incontinence, Urinary Frequency, Lower Urinary Tract Dysfunction, Primary Nocturnal Enuresis
Related terms Diurnal Enuresis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov