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Efficacy of Toltorodine Combined with Percutaneous Tibial Nerve Stimulation in the Treatment Ofpediatric over Active Bladder

Efficacy of Toltorodine Combined with Percutaneous Tibial Nerve Stimulation in the Treatment Ofpediatric over Active Bladder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105639
Enrollment
Unknown
Registered
2025-07-08
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Pediatric Over Active Bladder

Interventions

TTNS Group:3 times a week for 30 minutes
Tolterodine Group:0.1 mg/kg, twice a day
The Tolterodine Combined with TTNS Group:Percutaneous tibial nerve stimulation is applied at the same time as the drug

Sponsors

Children‘s Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Age =16 years, regardless of gender; (2) Meets the diagnostic criteria for refractory OAB; (3) Agrees to receive treatment with a wearable percutaneous tibial nerve stimulator; (4) Voluntarily participates in this clinical trial and signs the informed consent form; (5) Voiding diary (recorded for 3 days prior to randomization) indicates an average of =8 voids per 24 hours.

Exclusion criteria

Exclusion criteria: (1)Children with implanted cardiac pacemakers or defibrillators (as electrical stimulation may impact the safety of the devices); (2)Presence of uncontrolled symptomatic urinary tract infection, urolithiasis, urinary tuberculosis, or bladder tumors; (3)Children with renal insufficiency (serum creatinine levels exceeding 1.5 times the upper limit of normal); (4)Children with epilepsy, acute cerebrovascular disease, cognitive impairment, complete spinal cord injury, or psychiatric disorders;  (5)Skin lesions at the treatment site that preclude stimulation; (6)Presence of other comorbidities that could affect the efficacy of the trial.

Design outcomes

Primary

MeasureTime frame
Voiding Diary;OAB Symptom Score;

Countries

China

Contacts

Public ContactHeweiXu

Children‘s Hospital of Nanjing Medical University

xuhewei@njmu.edu.cn+86 158 9590 8861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026