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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02086058
Eligibility Criteria:
Inclusion Criteria:
Group 1: Group 1 (non-neurogenic bladder/overactive bladder):
* age 5-14 years of age
* patients must have filled out 48-hour bladder diaries
* a minimum of 4 micturitions per day (assessed from the bladder diaries)
* functional daytime urinary incontinence
* overactive bladder as defined by urgency
* no signs of neurogenic bladder dysfunction on invasive urodynamics
* a non-remarkable clinical examination
* normal BMI (between 3-97 percentile)
* informed oral and written consent from the child and both parents/legal guardian. In the informed consent the parents /legal guardian have given permission to the authorities (The Danish Ethical Committee), so that they may get information about the child during monitoring and quality inspection visits.
* no effect of prior treatment of at least 6 months urotherapy
* no effect of prior treatment of at least 3 months of anticholinergic treatment
* planned to undergo a cystoscopy under anesthesia
Group 2:
* 5-14 years of age or \>18 years old
* diagnosed with a neurogenic bladder (i.e. caused by myelomeningocele)
* informed oral and written consent from the child and both parents/legal guardian. In the informed consent the parents /legal guardian have given permission to the authorities (The Danish Ethical Committee), so that they may get information about the child during monitoring and quality inspection visits.
* planned to undergo a cystoscopy under anesthesia
Group 3:
* age 5-14 years of age or \>18 years old
* a non-remarkable clinical examination
* a normal voiding pattern
* a minimum of 3 micturitions per day
* planned to undergo a cystoscopy under anesthesia
Exclusion Criteria:
Group 1:
* Neurological and/or anatomical abnormalities in the lower urinary tract
* a medical history, clinical or biochemical tests that indicate that the child suffers from any type of disease (such as acute urinary infection or diabetes) or condition (such as pregnancy) influencing the child´s possibility of participating in the study, or that may effect the study parameters that are under examination.
* ongoing fecal problems such as fecal incontinence or constipation
* prior surgery involving the bladder
* ongoing urinary tract infections
* ongoing treatment with any type of medicine that may effect the study parameters that are under examination
Group 2:
* a medical history, clinical or biochemical tests that indicate that the child suffers from any type of diseases (such as diabetes) or conditions (such as pregnancy) influencing the child´s possibility of participating in the study, or that may affect the study parameters that are under examination.
* ongoing treatment with any type of medicine that may affect the study parameters that are under examination
Group 3:
* Neurological and/or anatomical abnormalities in the lower urinary tract
* urinary incontinence and an overactive bladder with urinary incontinence
* a medical history, clinical or biochemical tests that indicate that the patient suffers from any type of disease (such as acute urinary tract infection or diabetes) or condition (such as pregnancy) influencing the patient´s possibility of participating in the study, or that may effect the study parameters that are under examination.
* any type of bladder disease or any disease secondary affecting the bladder
* prior bladder surgery
* ongoing urinary tract infection
* ongoing treatment with any type of medicine that may effect the study parameters that are under examination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
80 Years
Study:
NCT02086058
Study Brief:
Protocol Section:
NCT02086058