Nocturnal Enuresis Clinical Trial
Official title:
Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg?
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
Status | Recruiting |
Enrollment | 150 |
Est. completion date | October 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 15 Years |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Benha University Hospitals | Banha | Qaliopia |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327. — View Citation
Blais AS, Nadeau G, Moore K, Genois L, Bolduc S. Prospective Pilot Study of Mirabegron in Pediatric Patients with Overactive Bladder. Eur Urol. 2016 Jul;70(1):9-13. doi: 10.1016/j.eururo.2016.02.007. Epub 2016 Feb 11. — View Citation
Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety o — View Citation
Neveus T, Fonseca E, Franco I, Kawauchi A, Kovacevic L, Nieuwhof-Leppink A, Raes A, Tekgul S, Yang SS, Rittig S. Management and treatment of nocturnal enuresis-an updated standardization document from the International Children's Continence Society. J Ped — View Citation
Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016 — View Citation
Park JS, Lee YS, Lee CN, Kim SH, Kim SW, Han SW. Efficacy and safety of mirabegron, a beta3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study. World J Urol. 2019 Aug;37(8):1665-1670. — View Citation
Vande Walle J, Rittig S, Bauer S, Eggert P, Marschall-Kehrel D, Tekgul S; American Academy of Pediatrics; European Society for Paediatric Urology; European Society for Paediatric Nephrology; International Children's Continence Society. Practical consensus — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | nocturnal enuresis improvement rate | decrease number of nights or absent nights the patient get wet | four months | |
Secondary | side effects of drugs used | appearance of any side effect of desmopressin or mirabegron | three months |
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