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Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial

Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial - The SENS U trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56214
Enrollment
219
Registered
2021-10-04
Start date
2023-03-10
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Lower urinary tract symptoms/ functional urinary incontinence

Interventions

Urotherapy with the SENS-U. The SENS-U is a wearable ultrasound device that continuously measures bladder filling and gives an alarm at a preset bladder filling (e.g. 80% filling). The SENS-U provid

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: • Age >= 6 years and = one episode a month , >= 3 months) • Diagnosed with overactive bladder, dysfunctional voiding or underactive bladder with or without recurrent urinary tract infections according ICCS criteria/classification • Eligible for urotherapy/ bladder training as the treatment of choice by the clinician • No current urinary tract infection (UTI) at the start of the study

Exclusion criteria

Exclusion criteria: • History of congenital urogenital anomalies except for successfully treated mild infravesical obstruction (meatal stenosis, mild urethral valves) 95th percentile according to age/gender. • Skin problems in the suprapubic area that are incompatible with the SENS-U adhesive • Developmental and intellectual disabilities or severe behavioural and social problems that are incompatible with protocolled urotherapy treatment based on the history and opinion of the clinician/ urotherapist.

Design outcomes

Primary

MeasureTime frame
Primary outcome is number of wetting accidents per week after 3 months of urotherapy.

Secondary

MeasureTime frame
Secondary outcomes are long term outcomes,, subjective experiences, adherence, voiding frequencies, post-void residuals and volume, uroflowmetry curves, and quality of life and cost effectiviness defined by QUALY's.

Countries

Netherlands

Contacts

Public ContactLL Wall

Radboud Universitair Medisch Centrum

Eline.vandewetering@radboudumc.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)