NovioMini II: Clinical Evaluation of a Full Bladder Notification - a feasibility study -

NovioMini II: Clinical Evaluation of a Full Bladder Notification - a feasibility study - - NovioMini II: Clinical Evaluation of a Full Bladder Notification

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44317

Enrollment

Registered

2018-01-15

Start date

2018-02-28

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

urinary incontinence

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: * Children who are scheduled for an inpatient bladder training * Children between the ages of 6 to 16 years. * Children are capable of understanding the procedure. * Parents / Guardians agree to let their child participate in the study.

Exclusion criteria

Exclusion criteria: * Patients with breached skin, open wounds, sutures or major scar tissue in the suprapubic region. * Patients with a suprapubic catheter (which prevents positioning the NovioMini properly) * Patients with severe obesity (BMI > 95th percentile, according to age/gender)

Design outcomes

Primary

Measure	Time frame
The main study parameter of this study is the full bladder notification success-rate. The notification success-rate is stated as the number of times the NovioMini notified the child of a full bladder prior to micturition, divided by the micturition frequency (number of times the child voided while wearing the NovioMini).	—

Secondary

Measure	Time frame
The second study parameter of this study is the level of compliance of the patient to respond to the NovioMini notification(s). The level of compliance is stated as the number of times the patient alerts the urotherapist/researcher of the notification, divided by the number of times the NovioMini notified the child of a full bladder prior to micturition. The final study parameters are (for each patient): micturition frequency, number of wet incidents (wet vs. dry), the bladder volumes and if urge symptoms occur, while wearing the NovioMini. Finally, the (differential) diagnoses, gender, age, length, weight, BMI, the time of voiding, time the NovioMini goes off, total wear time of the NovioMini will be documented for the children in the study. Based on these parameters, a description of the study population will be made.	—

Measure

Time frame

The second study parameter of this study is the level of compliance of the patient to respond to the NovioMini notification(s). The level of compliance is stated as the number of times the patient alerts the urotherapist/researcher of the notification, divided by the number of times the NovioMini notified the child of a full bladder prior to micturition. The final study parameters are (for each patient): micturition frequency, number of wet incidents (wet vs. dry), the bladder volumes and if urge symptoms occur, while wearing the NovioMini. Finally, the (differential) diagnoses, gender, age, length, weight, BMI, the time of voiding, time the NovioMini goes off, total wear time of the NovioMini will be documented for the children in the study. Based on these parameters, a description of the study population will be made.

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Countries

Netherlands

Outcome results