anticholinergic
DrugInitial anticholinergic therapy to all patients
Other names: Vesicare, BUP-4
NCT Number: NCT02845648
To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic enuresis and evaluate the potential implication of improved AA for treatment response prediction.
Looking for future studies?
Notify Me5 year–16 year
All sexes
Observational
Nocturnal enuresis is associated with three main etiologies, including nocturnal polyuria secondary to abnormal anti-diuretic hormone levels, low bladder capacity related to lower urinary tract dysfunction, and sleep disorders causing problems in arousal. Among them, the association between enuresis and lower urinary tract symptoms (LUTS) has gained importance. If these two conditions coexist, the diagnosis is nonmonosymptomatic enuresis (NME). The reported prevalence of LUTS among enuretic patients ranges widely from 21% to 99%. Moreover, it was reported that spontaneous resolution can be prolonged, and some cases of NME are likely to become refractory if treated like monosymptomatic enuresis (ME) cases. A possible explanation for this may be the presence of bladder dysfunction that is not addressed properly by the standard treatment of ME. However, this explanation is only speculative.
By showing a paradoxical increase in light sleep and higher cortical arousal index in enuretic children with reduced bladder capacity, one of the reason for impaired ability to awaken (AA) in enuretic patients may lie in the chronic stimulation of the bladder. This kind of bladder dysfunction leading to an abnormal bladder-brain dialogue has been further elaborated by an experiment showing brain dysfunction in the ventrolateral periaqueductal gray matter as a result of the experimental reduction of the bladder capacity. If this is true for enuretic children, we may be able to improve arousal (improved AA) by increasing their bladder capacity.
Based on this hypothesis, the present study aimed to evaluate to the effects of anticholinergic therapy with standard urotherapy on improvement of AA and show the effect of improved AA on treatment response in children with NME.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Initial anticholinergic therapy to all patients
Other names: Vesicare, BUP-4
Time frame: Baseline, 3 months and 6 months
Visual analog scale for ability to awaken (grade 1 = wake up before bed-wetting, grade 2 = wake up after bed-wetting, and grade 3 = failure of waking up around bed-wetting)
Time frame: Baseline, 3 months and 6 months
enuresis events as assessed by modified dysfunctional voiding symptoms score questionnaire (number of wet-nights per week, range 0 to 7)
Seoul National University Hospital
Other
The Ability to Awaken Can be Improved With Control of Lower Urinary Tract Symptoms in Children With Nonmonosymptomatic Enuresis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07108062
Behavior, Behavioral Symptoms
Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
View Trial DetailsNCT06508333
Behavior, Behavioral Symptoms
Chongqing, Chongqing Municipality, China
View Trial DetailsNCT04260646
Behavior, Behavioral Symptoms
Aalborg, Denmark
View Trial DetailsNCT01645475
Behavior, Behavioral Symptoms
Ghent, Belgium
View Trial Details