Childhood extraordinary daytime urinary frequency-a case series and a systematic literature review.
Manuela Bergmann, Teresa Corigliano, Iris Ataia...
https://pubmed.ncbi.nlm.nih.gov/19093136Actively Recruiting
Phase Not Applicable
Age: 5Years - 18Years
All Genders
ID07000656
Micturition Desire-Relaxation Training Device for Treating Lower Urinary Tract Dysfunction in Children: A Randomized Controlled Pilot Study
Led by Shanghai Children's Medical Center · Updated on 2025-06-05
200
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Lower urinary tract dysfunction (LUTD) in children involves problems with urine storage and voiding, often linked to abnormal reflexes formed in the central nervous system. Relaxation has been shown to help improve these functions. This trial evaluates a new Micturition Desire-Relaxation Training Device designed to help children with LUTD by training them to link the sensation of needing to urinate with a relaxed state. The study is a randomized controlled trial conducted over six months to assess the device's clinical effects. Participants are randomly assigned to either the intervention group using the active Micturition Desire-Relaxation Training Device or a sham group using an inactive device. In the intervention group, children will do supervised training sessions followed by home use of the device, performing 5 to 10 daily sessions lasting about 10 minutes each over eight weeks. The sham group follows the same training schedule but uses a non-functioning device for four weeks. Both groups maintain fluid intake and voiding diaries with monthly records, and caregivers receive remote support from study physicians. Throughout the study, participants complete voiding diaries and enuresis questionnaires at baseline, during treatment, and at 3 and 6 months post-intervention to monitor symptom changes and recurrence. Daily training adherence and any adverse events are recorded and reviewed by physicians through a secure cloud platform. The trial measures outcomes such as improvement rates in enuresis, daytime urinary incontinence frequency, total voiding episodes, and various bladder function and behavioral assessments, tracking progress over the full six-month period.
CONDITIONS
Brief Title
Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children
Who Can Participate
Age: 5Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 18 years inclusive
- Diagnosed with nocturnal enuresis, daytime urinary incontinence, or urinary frequency according to ICCS criteria
- For nocturnal enuresis: at least one involuntary nighttime urination episode per month for over 3 months, with no abnormal urinalysis or long bedwetting-free periods
- For daytime urinary incontinence: at least one intermittent leakage episode during wakefulness per month for over 3 months, without anatomical or neurological causes
- For urinary frequency: frequent small volume urination during the day and before sleep with normal total daily urine volume
- Voluntary participation with signed informed consent from child and guardian
You will not qualify if you...
- Enuresis caused by urinary tract infections, pinworms, myelitis, spinal cord injury, epilepsy, cerebral developmental disorders, diabetes, or other neurological, urinary, or endocrine diseases
- Transient enuresis related to excessive activity, mental fatigue, or excess fluid intake before bedtime
- Urinary frequency caused by neurogenic bladder, urinary infections, urethral syndrome, hypercalciuria, or metabolic diseases
- Participation in other clinical trials within the past month
- Investigator-assessed unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment and Training Instruction
Duration - 1 week
Participants complete baseline voiding diaries and receive supervised instruction on device usage and bladder relaxation techniques.
1 baseline visit with initial supervised sessions
Treatment
Duration - 8 weeks for intervention group; 4 weeks for sham group
Participants use the Micturition Desire-Relaxation Training Device or a sham device at home with multiple daily sessions. Caregivers receive remote support while participants maintain daily records including urine output and session details.
Daily home sessions; 3-4 initial supervised sessions; monthly record submissions
Follow-up Assessments
Duration - Up to 4 months after treatment ends
Participants complete voiding diaries and questionnaires at 3 and 6 months post-treatment to assess symptom changes and recurrence.
2 follow-up visits at 3 and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Micturition Desire-Relaxation Training
Shanghai, Shanghai Municipality, China, 200122
Actively Recruiting
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Research Team
J
jun ma
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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Published Research Related To This Trial
The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society.
Paul F Austin, Stuart B Bauer, Wendy Bower...
https://pubmed.ncbi.nlm.nih.gov/24508614