Relaxation-based bladder training device for children with daytime wetting, frequent urination, or bedwetting

Prospective Evaluation of Micturition Desire-Relaxation Training Device for Treating Lower Urinary Tract Dysfunction in Children: A Randomized Controlled Pilot Study

This trial will test whether a new relaxation-based device helps children with daytime urinary incontinence, urinary frequency, or primary nocturnal enuresis improve bladder control.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 5 Years to 18 Years
• Sex: All
• Sponsor: Shanghai Children's Medical Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07000656 on ClinicalTrials.gov

What this trial studies

This randomized, sham-controlled trial will enroll children with lower urinary tract dysfunction and use stratified block randomization by sex, age, and enuresis frequency to allocate participants 1:1 to the active device or a sham device. The first training session is supervised and caregivers receive standardized instruction, after which the device is used at home for an 8-week training period with frequent short sessions and remote physician support. Families keep daily records, upload urine images and session data to a secure cloud platform, and provide monthly fluid and voiding logs with follow-up extending to six months. Outcomes compare symptom frequency and bladder function between groups to determine clinical efficacy.

Who should consider this trial

Good fit: Children meeting ICCS criteria for daytime urinary incontinence, urinary frequency, or primary nocturnal enuresis without anatomical or neurological causes and with normal urinalysis are ideal candidates.

Not a fit: Children with structural urinary tract abnormalities, neurological disorders, active urinary tract infection, or other organic causes of incontinence are unlikely to benefit from this behavioral device.

Why it matters

Potential benefit: If successful, the device could reduce leakage, urgency episodes, and bedwetting and improve bladder storage and voiding function without medications.

How similar studies have performed: Behavioral bladder training and relaxation approaches have shown benefit in pediatric LUTD, but this specific Micturition Desire-Relaxation Training Device is novel and has not been previously tested in clinical trials.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Age: 5 to 18 years (inclusive), regardless of gender.
3. Voluntary participation: The child and their guardian must voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. 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.
2. Exclude conditions causing urinary frequency such as neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases.
3. Patients who have participated in or are currently participating in other clinical trials within the past month.
4. Patients deemed unsuitable for participation in the clinical trial by the investigator.

Where this trial is running

Shanghai, Shanghai Municipality

• Micturition Desire-Relaxation Training — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: jun ma

Conditions Daytime Urinary Incontinence; Urinary Frequency; Lower Urinary Tract Dysfunction; Primary Nocturnal Enuresis