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

Completed

Conditions: urinary incontinence
10004994

Registration Number: NL-OMON44317

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

* 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)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter of this study is the full bladder notification<br /><br>success-rate. The notification success-rate is stated as the number of times<br /><br>the NovioMini notified the child of a full bladder prior to micturition,<br /><br>divided by the micturition frequency (number of times the child voided while<br /><br>wearing the NovioMini).</p><br>

Secondary Outcome Measures

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