SENS-U (TM) Bladder Sensor: continuous home monitoring of natural nocturnal bladder filling in children with nocturnal enuresis * an observational study

SENS-U (TM) Bladder Sensor: continuous home monitoring of natural nocturnal bladder filling in children with nocturnal enuresis * an observational study - SENS-U (TM): continuous monitoring of nocturnal bladder filling

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46080

Enrollment

Registered

2018-09-17

Start date

2018-10-11

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Bedwetting Nocturnal Enuresis

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Monosymptomatic nocturnal enuresis - age between 6 to 12 years (

Exclusion criteria

Exclusion criteria: - small bladder capacity : less than 65% of the expected bladder capacity - breached skin, open wounds, sutures or major scar tissue in the suprabubic region - nightly use of a (suprabubic) catheter

Design outcomes

Primary

Measure	Time frame
The main study parameter is the total number of natural nocturnal bladder filling cycles. This requires an increase in anterior-posterior bladder dimension over the time of one filling cycle.	—

Secondary

Measure	Time frame
The second study parameter is the position transition factor to determine the influence of sleep position on A-P bladder dimension. This transition factor is defined as the A-P dimension of the old position divided by the bladder dimension of the new position. The final study parameter is the theoretical notification success-rate. Other parameters which are documented are: A-P bladder dimensions (mm), voided volumes (mL), weight of diaper (mg), voiding times (hh:mm), body position, contact adhesive and skin and spout of gel. In addition, differential diagnosis, gender, age, length, weight, abdominal girth (cm) of the 15 children will be documented.	—

Measure

Time frame

The second study parameter is the position transition factor to determine the influence of sleep position on A-P bladder dimension. This transition factor is defined as the A-P dimension of the old position divided by the bladder dimension of the new position. The final study parameter is the theoretical notification success-rate. Other parameters which are documented are: A-P bladder dimensions (mm), voided volumes (mL), weight of diaper (mg), voiding times (hh:mm), body position, contact adhesive and skin and spout of gel. In addition, differential diagnosis, gender, age, length, weight, abdominal girth (cm) of the 15 children will be documented.

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Countries

Netherlands

Outcome results