Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT04147793
Eligibility Criteria:
Inclusion Criteria All subjects • Age 7-16 years inclusive
Controls
* Concurrent urological disease requiring surgery which includes cystoscopy
* No significant urinary symptoms
* No day-time urinary incontinence
* Urinary frequency 4-7 per day
* No history of recurrent urinary infections (more than two infections in previous year)
* Has not passed a renal tract stone
Overactive sphincter
* Require VCMG as part of their clinical care
* A prior diagnosis of dysfunctional voiding. This will have been made in a neurologically intact child following previous non-invasive bladder investigation including two representative urine flows that demonstrate the following (Austin et al., 2014):
* Intermittent and/or fluctuating flow rate
* Pelvic EMG activity during voiding
* either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)
Underactive sphincter
* Have either:
* Symptoms of stress urinary incontinence
* Or urinary incontinence with a neuropathic bladder
* Require VCMG as part of their clinical care.
* either perform intermittent catheterisation or have no contraindication to Entonox sedation (see below)
* For the UPP data to be included for analysis their videocystometry should demonstrate o Stress urinary incontinence: defined as involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction (Austin et al., 2014)
Exclusion Criteria:
* Unaccompanied by adult with parental responsibility who can give consent
* Previous bladder outlet or urethral surgery
* Other urological disease not mentioned specifically in the treatment group inclusion criteria; including posterior urethral valves, cerebral palsy, inherited metabolic disease
* Contraindication to Entonox if sedation required for catheter insertion:
* Conditions where gas may be trapped in a body cavity, eg middle ear occlusion, intestinal obstruction
* Unable to understand instruction for use of Entonox
* Evidence urinary tract infection on day UPP measurement
* Symptoms of dysuria
* Abnormally cloudy or offensive urine
* Temperature of 38oc or more
* Urine dipstick positive nitrates or leucocytes on the day of the study, in the absence of a renal tract stone or indwelling catheter
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
16 Years
Study:
NCT04147793
Study Brief:
Protocol Section:
NCT04147793