Prospective Evaluation of Micturition Desire-Relaxation Training Device for Treating Lower Urinary Tract Dysfunction in Children: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Enuresis improvement rate
研究概览
简要总结
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.
详细描述
This randomized controlled trial aims to evaluate the clinical efficacy of the Micturition Desire-Relaxation Training Device in managing LUTD in children over a six-month period. A stratified block randomization method will be used, matching participants based on sex, age, and enuresis frequency. Eligible participants will be stratified by sex and age, and then randomly assigned (1:1) to either the intervention group or the sham intervention group using a computer-generated sequence. This method ensures group balance regarding baseline characteristics and enuresis severity.
In the intervention group, baseline voiding diaries will be completed prior to initiating training. The first session will be supervised by trained medical personnel, during which participants and caregivers will receive standardized instruction in device usage and bladder relaxation techniques. Each session will last approximately 10 minutes and will be conducted 3-4 times during the initial instructional phase. The device will then be provided for home use at no cost. Caregivers will receive remote support from study physicians during the intervention period. Home-based training will include 5-10 sessions per day, each lasting 10 minutes. Daily records-including images of urine output, session duration, and any adverse events-will be uploaded to a secure cloud platform for physician review. The intervention will continue for 8 weeks. Monthly records of fluid intake and voiding behavior will be maintained throughout the study. Follow-up assessments, including voiding diaries and enuresis questionnaires, will be performed at 3 and 6 months post-intervention to assess recurrence and long-term outcomes.
The sham group will follow identical baseline and training schedules; however, the device will remain inactive during each session. After 4 weeks, participants in this group will submit fluid intake and voiding records.
Primary outcome measures include the enuresis improvement rate, frequency of daytime urinary incontinence, and total number of voiding episodes within 24 hours. Secondary outcomes will include: scores for the micturition desire-awakening function, timing of enuresis events, bedtime and wake time, standardized bladder capacity, bladder variability rate, behavioral responses during incontinence, psychological/behavioral characteristics, and enuresis recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis according to the ICCS criteria:
- •For nocturnal enuresis:
- •At least one episode of involuntary nighttime urination per month for more than 3 months.
- •No abnormalities in routine urinalysis. No period of bedwetting-free days lasting more than 6 months, except for organic diseases.
- •For daytime urinary incontinence:
- •At least one episode of intermittent urinary leakage during wakefulness per month for more than 3 months.
- •No anatomical or neurological causes of urinary incontinence.
- •For urinary frequency:
- •The child experiences only urinary frequency and urgency, occurring during the day and before sleep, with intervals ranging from a few minutes to 1 hour. Each urination involves a small volume, less than 50% of the estimated bladder capacity [EBC (mL) = 30 + (age × 30)], typically less than 30 mL, sometimes just a few drops, while total daily urine volume remains within normal limits. When the child is engaged in play or focused, the intervals between urination are extended, and urinary frequency symptoms disappear after falling asleep.
- •Age: 5 to 18 years (inclusive), regardless of gender.
- •Voluntary participation: The child and their guardian must voluntarily participate in the trial and sign the informed consent form.
排除标准
- •Exclude enuresis caused by urinary tract infections, pinworms, myelitis, spinal cord injuries, epilepsy, cerebral developmental disorders, diabetes, and other neurological, urinary, or endocrine diseases, as well as transient enuresis due to excessive activity, mental fatigue, or excessive fluid intake before bedtime.
- •Exclude conditions causing urinary frequency such as neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases.
- •Patients who have participated in or are currently participating in other clinical trials within the past month.
- •Patients deemed unsuitable for participation in the clinical trial by the investigator.
研究组 & 干预措施
Sham Intervention Group
This arm will enroll pediatric participants diagnosed with PNE, daytime urinary incontinence, or urinary frequency disorder according to the ICCS diagnostic criteria. Participants will follow the same baseline assessment protocol and stratified randomization based on sex, age, and enuresis frequency. They will undergo sham Micturition Desire-Relaxation Training, during which the device will remain inactive throughout each session. Training sessions will last approximately 10 minutes and be performed 5 to 10 times daily for a total of 4 weeks. A fluid intake and voiding diary will be submitted at the end of the sham training period. Participants will continue with follow-up assessments at 3 and 6 months post-intervention to evaluate natural symptom progression and recurrence, without further training.
干预措施: Sham device (Device)
Micturition Desire-Relaxation Training
This study includes children diagnosed with PNE, daytime urinary incontinence, and urinary frequency disorder according to the ICCS diagnostic criteria. Participants in the intervention group will undergo Micturition Desire-Relaxation Training, with each session lasting approximately 10 minutes, performed 5 to 10 times per day over an 8-week period. Changes in clinical symptoms and any adverse events will be systematically documented at baseline, and at 1 and 2 months during the intervention, as well as at 3 and 6 months post-treatment. For participants who achieve complete remission, caregivers will be asked to maintain daily records of enuresis episodes at 3 and 6 months after treatment to monitor potential recurrence.
干预措施: Micturition Desire-Relaxation Training Device (Device)
结局指标
主要结局
Enuresis improvement rate
时间窗: From enrollment to the end of treatment at 6 months
The enuresis improvement rate is the sum of the complete and partial response rates. No response: \<50% reduction. Partial response: 50 to 99% reduction. Complete response: 100% reduction.
Daytime urinary incontinence frequency
时间窗: From enrollment to the end of treatment at 6 months
The frequency of daytime urinary incontinence will be recorded using a voiding diary, with caregivers documenting each episode of urine leakage during waking hours. The daily frequency will be categorized using a study-specific ordinal scoring system as follows: Score 0: No daytime incontinence Score 1: ≤1 episode/day Score 2: 2-3 episodes/day Score 3: ≥4 episodes/day Higher scores indicate more severe daytime urinary incontinence.
Total number of voiding episodes in 24 hours
时间窗: From enrollment to the end of treatment at 6 months
The total number of voiding episodes per 24 hours will be calculated using a 3-day bladder diary. This includes both daytime and nighttime voids.
次要结局
- Grade scoring of the micturition desire - awakening function(From enrollment to the end of treatment at 6 months)
- Enuresis recurrence rate(From enrollment to the end of treatment at 6 months)
- Timing of nocturnal enuresis episodes(From enrollment to the end of treatment at 6 months)
- Child's bedtime and wake time(From enrollment to the end of treatment at 6 months)
- Standardized bladder capacity(From enrollment to the end of treatment at 6 months)
- Bladder variability rate(From enrollment to the end of treatment at 6 months)
- Behavioral response during daytime urinary incontinence episodes(From enrollment to the end of treatment at 6 months)
- Child's psychological and behavioral characteristics(Assessed every 3 months from enrollment to the end of treatment at 6 months)