Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children
Phase: PHASE3
Conditions: Treatment of Non-monosymptomatic Nocturnal Enuresis
Sponsor: Menoufia University

 
Efficacy of mirabegron for treatment of nocturnal enuresis in 
children 
Introduction 
Enuresis is an extremely common condition, which, although somatically benign, 
poses long-term psychosocial risks if untreated.  
Nocturnal enuresis (NE) or bedwetting is defined as the voluntary or involuntary 
wetting of clothes or bedding with urine for a period of at least 3 consecutive 
months in children older than 5 years of age. It affects 15% - 20% of children aged 
5 years, and 1% - 2% of adolescents[2]. Although spontaneous recovery occurs at a 
rate of 10–15% per year[3], NE still has a certain impact on the child’s social, 
emotional and psychological development. According to the International 
Children’s Continence Society (ICCS) recommendation, NE can be subclassified 
into monosymptomatic nocturnal enuresis (MNE) and non-monosymptomatic 
nocturnal enuresis (NMNE) based on whether accompanied with lower urinary 
tract symptoms (LUTS) or not[4]. MNE is defined as involuntary urine voiding 
during sleep without other LUTS, such as daytime urinary frequency, urgency, or 
incontinence of urine. More than 68.5% of NE patients are MNE[5]. 
Various interventions including pharmacological, behavioral and other approaches 
have been used for the treatment of MNE. Alarm therapy, one of the first line 
treatment, has been proved to be effective for MNE and should be first taken into 
consideration in children under 8 year age with adequate family support[6]. 
Desmopressin is the most widely used medical treatment in the management of 
MNE[7]. Combine therapy of desmopressin plus anticholinergics is often taken 

into consideration when the patients are refractory to single treatment, having 
behavioral problems or frequent nighttime enuresis[8]. 
Aim  
To evaluate the efficacy of B3 agonist mirabegron in the management of nocturnal 
enuresis in children. 
Patients &Methods:  
The study will be conducted in urology department, Menoufia University Hospital. 
Sample size: 151 
Inclusion criteria: 
Children from 5-15 years old 
Nocturnal enuresis 
Exclusion criteria: 
Patients with anatomical lower urinary tract abnormalities  
Any neurological diseases 
Experienced treatment failure 
Active urinary tract infection 
Preintervention assessment: 
Laboratory investigations:  
Urine analysis and urine culture & sensitivity 
Radiological investigation: 

 Ultrasound abdomen and pelvis  
The main outcomes included complete response rate, success rate, mean number of 
wet nights per week at the end of treatment, relapse rate at the end of following up, 
and adverse events during the treatment. According to the definition of ICCS, the 
outcomes were evaluated as follows: (1) complete response (CR) as a 100 % 
decrease; (2) response (R) as a ≥90 % decrease; (3) partial response (PR) as a 50–
89 % decrease; (4) non-response (NR) as 0–49 % decrease in the number of wet 
nights. Relapse was defined as reappearance of >1 wet night per week for complete 
responders or >50% of pretreatment wetting frequency for partial responders. CR, 
R, and PR were regarded as the success. 
Results:  
 
The results will be recorded, tabulated, and statistically analyzed. 
 
Discussion: 
 
The results will be discussed in comparison to those mentioned in the 
literature. 
References: 
1. Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, et al. 
The standardization of terminology of lower urinary tract function in children 
and adolescents: report from the Standardisation Committee of the 
International Children's Continence Society. The Journal of urology. 
2006;176(1):314-24. 
2. Neveus T. Nocturnal enuresis-theoretic background and practical guidelines. 
Pediatric nephrology (Berlin, Germany). 2011;26(8):1207-14.  

3. Cakiroglu B, Tas T, Eyyupoglu SE, Hazar AI, Can Balci MB, Nas Y, et al. 
The adverse influence of spina bifida occulta on the medical treatment 
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di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia 
urologica e nefrologica.2014;86(4):270-3. 
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10.1080/00365590410025460. PubMed PMID: 15204373. 
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al. Desmopressin treatment regimens in monosymptomatic and 
nonmonosymptomatic enuresis: A review from a clinical perspective. Journal 
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WOS:000291195600003.  
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