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

Recruiting

Conditions: Lower urinary tract symptoms/ functional urinary incontinence
10046590

Registration Number: NL-OMON56214

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 480

Inclusion Criteria

• Age >= 6 years and < 16 years
• Presenting with functional daytime urinary incontinence according to previous
definition ( >= 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

• History of congenital urogenital anomalies except for successfully treated
mild infravesical obstruction (meatal stenosis, mild urethral valves) < 3
months before inclusion
• History of neurological underlying disease
• Untreated or treated but persisting functional constipation according to Rome
IV criteria at the start of the study < 6 months before inclusion.
• Recurrent culture proven UTI (less than 3 months before start of the study or
not under control by prophylactic antibiotics)
• Previous urotherapy/ bladder training within 6 months of start of the study
• Adipositas preventing accurate measurement by the SENS-U as defined as a BMI
> 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is number of wetting accidents per week after 3 months of<br /><br>urotherapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are long term outcomes,, subjective experiences, adherence,<br /><br>voiding frequencies, post-void residuals and volume, uroflowmetry curves, and<br /><br>quality of life and cost effectiviness defined by QUALY's.</p><br>