NL-OMON56214
Recruiting
Not Applicable
Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial - The SENS U trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower urinary tract symptoms/ functional urinary incontinence
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 480
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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