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An Exploratory Study on the Efficacy and Safety of Wearable Non-invasive Transcutaneous Tibial Nerve Stimulation for Treating Overactive Bladder in Children

An Exploratory Study on the Efficacy and Safety of Wearable Non-invasive Transcutaneous Tibial Nerve Stimulation for Treating Overactive Bladder in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121730
Enrollment
Unknown
Registered
2026-04-02
Start date
2026-04-07
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric overactive bladder (POAB)

Interventions

Intervention group:Wearable non-invasive transcutaneous tibial nerve stimulation (TTNS) therapy

Sponsors

Beijing Childrens Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.In accordance with the 2021 'Chinese Expert Consensus on the Diagnosis and Treatment of Pediatric Overactive Bladder', the diagnostic criteria for pediatric overactive bladder. 2.Aged between 6 and 18 years; 3.No response to behavioral therapy for at least 4 weeks; 4.No response to medication for at least 4 weeks or parents refuse medication treatment; 5.The child and their guardian voluntarily participate in this trial and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Subjects with other organic or psychiatric diseases that severely affect health and cooperation with doctor; 2.Secondary overactive bladder; 3.Subjects with hypertension, fluid or electrolyte imbalances before treatment, and those who should be excluded; 4.Subjects with a pacemaker or implanted defibrillator; 5.Subjects who have participated in or are currently participating in other clinical trials within the past month; 6.Subjects with poor compliance who cannot complete the treatment cycle; 7.Subjects judged by the investigator to be unsuitable for participation in the clinical trial;

Design outcomes

Primary

MeasureTime frame
Relief of urinary frequency, urgency, incontinence, nocturnal enuresis, average bladder capacity, and maximum bladder capacity;

Secondary

MeasureTime frame
Post-void residual volume;American Urological Association Symptom Index (AUA-SI) score;AUA Quality of Life (AUA-SI-QOL) score;Overactive Bladder Symptom Score (OABSS) Score;Patient Perception of Bladder Condition-Symptoms (PPBC-S) score;

Countries

China

Contacts

Public ContactLiu Xiaomei

Beijing Childrens Hospital,Capital Medical University

xmliu16@163.com+86 10 59616860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026