Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis

NCT ID: NCT05617664

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2023-10-31

Brief 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

Detailed Description

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

Conditions

Nocturnal Enuresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with primary nocturnal enuresis will be followed up with behavioral therapy alone.

Group Type: PLACEBO_COMPARATOR

behavioral therapy alone

Intervention Type: BEHAVIORAL

no medications will be given to the patient

patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets.

Group Type: ACTIVE_COMPARATOR

desmopressin 120 mcg oral tablets

Intervention Type: DRUG

treatment for three months then will stop

patients with PNE will take mirabegron 25 mg oral tablets.

Group Type: ACTIVE_COMPARATOR

Mirabegron 25 MG Oral Tablet, Extended Release

Intervention Type: DRUG

treatment for three months then will stop

Interventions

desmopressin 120 mcg oral tablets

treatment for three months then will stop

Intervention Type: DRUG

Mirabegron 25 MG Oral Tablet, Extended Release

treatment for three months then will stop

Intervention Type: DRUG

behavioral therapy alone

no medications will be given to the patient

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Hosam Abu El-nasr

lecturer of urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospitals

Banhā, Qaliopia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hosam abu el-nasr, MD

Role: CONTACT

hosamabuelnasr@gmail.com

01286296939 ext. 002

mohamed al hefnawy, MD

Role: CONTACT

dr.mohamedalhefnawy@gmail.com

01003481084 ext. 002

Facility Contacts

hosam abu el-nasr, MD

Role: primary

hosamabuelnasr@gmail.com

01286296939 ext. 002

References

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.

Reference Type: RESULT

PMID: 25086164 (View on PubMed)

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/j.juro.2013.05.062. Epub 2013 May 30.

Reference Type: RESULT

PMID: 23727415 (View on PubMed)

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 of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13.

Reference Type: RESULT

PMID: 23769122 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26876327 (View on PubMed)

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. doi: 10.1007/s00345-018-2576-0. Epub 2018 Dec 3.

Reference Type: RESULT

PMID: 30511212 (View on PubMed)

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 guidelines for the management of enuresis. Eur J Pediatr. 2012 Jun;171(6):971-83. doi: 10.1007/s00431-012-1687-7. Epub 2012 Feb 24.

Reference Type: RESULT

PMID: 22362256 (View on PubMed)

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 Pediatr Urol. 2020 Feb;16(1):10-19. doi: 10.1016/j.jpurol.2019.12.020. Epub 2020 Jan 30.

Reference Type: RESULT

PMID: 32278657 (View on PubMed)

Other Identifiers

treatment of primary nocturnal

Identifier Type: -

Identifier Source: org_study_id