Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 20, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Daytime Urinary IncontinenceUrinary FrequencyLower Urinary Tract DysfunctionPrimary Nocturnal Enuresis
Interventions
DEVICE

Micturition Desire-Relaxation Training Device

The device was developed by Shanghai Children's Medical Center in collaboration with Shanghai University of Engineering Science. It plays relaxation videos through a VR device and monitors the subjects' brain waves in real time using electroencephalography to evaluate their relaxation levels. The relaxation material is adjusted accordingly, and urination is recorded after training. Urine is collected and analyzed with a flow meter, generating a diagnostic report.

DEVICE

Sham device

Participants diagnosed with nocturnal enuresis, daytime urinary incontinence, and urinary frequency will be screened at Shanghai Children's Medical Center, and eligible patients will be recruited. Participants will be randomly assigned to the sham training group, in which they will wear the device without powering it on for 10 minutes each session, 5-10 times a day, for 4 weeks.

Trial Locations (1)

200122

RECRUITING

Micturition Desire-Relaxation Training, Shanghai

All Listed Sponsors
lead

Shanghai Children's Medical Center

OTHER