DRUG
desmopressin 120 mcg oral tablets
treatment for three months then will stop
Status
Unknown
Phase
Not applicable
Enrollment
150
Locations
1
Results
Not posted
Publications
7
Study summary
Investigators will study the efficacy and safety of mirabegron25 in treatment of primary nocturnal enuresis in comparison to oral desmopressin 120 mcg and behavioral therapy
No doubt that nocturnal enuresis is one of the commonest types of urinary incontinence which affect children and always run in family . Nocturnal enuresis occurs at the age of 5 years with leakage of urine involuntarily during sleep for two times or more per week in three consecutive months not due to congenital or acquired cause. Nocturnal enuresis can be categorized into primary or secondary depending on occurrence of bed dryness for more than six months or not . Nocturnal enuresis affects 15% to 20 % of children at five years old mainly due to delay of bladder development and function more in male children with presence of family history in half of cases but 15% of children with enuresis recover spontaneously every year . limitation of fluid intake, urotherapy and bedwetting alarms are non-pharmacological treatments of nocturnal enuresis while the mostly used drugs for treatment of NE are tricyclic antidepressants(Imipramine®) an arginine vasopressin analog (Desmopressin®) and anticholinergic drugs . Enuresis alarms have pitfalls which disgust a lot of patients as skin irritation, sleep disturbances of other family members and failure to wake the child so that about 30% of patients stop its usage . Desmopressin is approved as a first-line drug therapy for nocturnal enuresis , but a lot of series declared that monotherapy with desmopressin has little efficacy in treating patients which have bladder storage dysfunction furthermore, high recurrence rate after treatment cessation . The International Children's Continence Society (ICCS) recommended combination therapy for treatment of primary nocturnal enuresis after failure of first line therapy with desmopressin or enuresis alarms . As regard anticholinergic drugs, oxybutynin was firstly prescribed then tolterodine with less side effects and lately solifenacin . Cognitive impairment as a neurological side effect was authenticated for oxybutynin and other side effects (e.g. headache, dry mouth, behavior change, flushed cheeks, constipation, and blurred vision) were unbearable to many children and impulsed them to stop treatment early . Mirabegron, a b3-adrenoceptor (b3-AR) agonist was the answer to the question about a drug that can relax detrusor muscle and increasing bladder capacity without the limitations of anti-cholinergic drugs. Mirabegron is the first b3-AR agonist to be prescribed clinically for OAB symptoms in adults and showed promising outcomes . while it is not licensed to be used in children with overactive bladder, some early reports declared its efficacy and tolerability in children . So investigators will study the efficacy and safety of mirabegron in treatment of primary nocturnal enuresis
Interventions
DRUG
treatment for three months then will stop
DRUG
treatment for three months then will stop
BEHAVIORAL
no medications will be given to the patient
Timeline
First posted
Nov 15, 2022
Study start
Nov 23, 2022
Primary completion
Sep 2023
Study completion
Oct 2023
Results posted
Not reported
Registry updated
Aug 3, 2023
Outcomes
nocturnal enuresis improvement rate
Time frame · four months
decrease number of nights or absent nights the patient get wet
side effects of drugs used
Time frame · three months
appearance of any side effect of desmopressin or mirabegron
Eligibility
Inclusion Criteria: * primary nocturnal enuresis, * negligible daytime wetting, * wet at least 4 times over 4 weeks * normal clinical examination with no neurological or urological cause for the enuresis Exclusion Criteria: * secondary enuresis, polysymptomatic * neurologic bladder, neurological disorders, * urinary incontinence disorders * previous anti NE drugs.
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Benha University Hospitals
Banhā, Qaliopia, Egypt
Publications
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