Evaluation of the SENS-U as an alarm intervention in the treatment of children with 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44345202

Enrollment

480

Registered

2022-03-23

Start date

2022-02-01

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Treatment of children with functional daytime urinary incontinence Other

Interventions

Participants will be divided into 3 arms in a 1:1:1 fashion: 1. Urotherapy only (control group) 2. Urotherapy + SENS-U 3. Urotherapy + Sham-device (placebo) Urotherapy will be given for 3 months. Chil

Eligibility

Sex/Gender

All

Age

6 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 6 and 15 years 2. Functional daytime urinary incontinence 3. Diagnosed with overactive bladder, dysfunctional voiding, or underactive bladder according to ICCS criteria 4. Eligible for urotherapy

Exclusion criteria

Exclusion criteria: 1. History of congenital urogenital anomalies except for successfully treated mild infravesical obstruction 2. History of neurological underlying disease 3. History of botox treatment for lower urinary tract dysfunction (LUTD) 4. Untreated or treated but persisting functional constipation according to Rome IV criteria 95th percentile according to age/gender 8. Skin problems in suprapubic area that are incompatible with the SENS-U adhesive 9. Developmental and itellectual disabilities or severe behavioural and social problems that are incompatible with protocolled urotherapy treatment based on the history and on the opinion of the clinician/urotherapist

Design outcomes

Primary

Measure	Time frame
Number of 'wetting accidents' per week measured by questionnaires at baseline and 3 months	—

Secondary

Measure	Time frame
1. Subjective improvement of LUTS according to parents using questionnaires at baseline, 3, and 6 months 2. Change in urinary incontinence during follow-up measured using the number of wetting accidents per week at 6 months 3. Change in frequency voiding chart parameters (average, minimum, maximum void volumes corrected for bladder capacity for age (EBC) measured using voiding charts at baseline, 3, and 6 months 4. Change in Quality of Life measured using questionnaires at baseline, 3, and 6 months 5. Cost-effectiveness measured using questionnaires set out to costs at 6 months 6. Magnitude of the placebo-effect measured using number of wetting accidents per week at baseline and 3 months	—

Measure

Time frame

1. Subjective improvement of LUTS according to parents using questionnaires at baseline, 3, and 6 months 2. Change in urinary incontinence during follow-up measured using the number of wetting accidents per week at 6 months 3. Change in frequency voiding chart parameters (average, minimum, maximum void volumes corrected for bladder capacity for age (EBC) measured using voiding charts at baseline, 3, and 6 months 4. Change in Quality of Life measured using questionnaires at baseline, 3, and 6 months 5. Cost-effectiveness measured using questionnaires set out to costs at 6 months 6. Magnitude of the placebo-effect measured using number of wetting accidents per week at baseline and 3 months

—

Countries

Netherlands

Contacts

Public ContactEline van de Wetering

Eline.vandewetering@radboudumc.nl+31615188436

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026