search
Back to results

Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis

Primary Purpose

Nocturnal Enuresis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
desmopressin 120 mcg oral tablets
Mirabegron 25 MG Oral Tablet, Extended Release
behavioral therapy alone
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Enuresis

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Benha University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

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

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

patients with PNE will take mirabegron 25 mg oral tablets.

Arm Description

Outcomes

Primary Outcome Measures

nocturnal enuresis improvement rate
decrease number of nights or absent nights the patient get wet

Secondary Outcome Measures

side effects of drugs used
appearance of any side effect of desmopressin or mirabegron

Full Information

First Posted
November 8, 2022
Last Updated
August 2, 2023
Sponsor
Benha University
search

1. Study Identification

Unique Protocol Identification Number
NCT05617664
Brief Title
Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis
Official Title
Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with primary nocturnal enuresis will be followed up with behavioral therapy alone.
Arm Type
Placebo Comparator
Arm Title
patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets.
Arm Type
Active Comparator
Arm Title
patients with PNE will take mirabegron 25 mg oral tablets.
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
desmopressin 120 mcg oral tablets
Intervention Description
treatment for three months then will stop
Intervention Type
Drug
Intervention Name(s)
Mirabegron 25 MG Oral Tablet, Extended Release
Intervention Description
treatment for three months then will stop
Intervention Type
Behavioral
Intervention Name(s)
behavioral therapy alone
Intervention Description
no medications will be given to the patient
Primary Outcome Measure Information:
Title
nocturnal enuresis improvement rate
Description
decrease number of nights or absent nights the patient get wet
Time Frame
four months
Secondary Outcome Measure Information:
Title
side effects of drugs used
Description
appearance of any side effect of desmopressin or mirabegron
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hosam abu el-nasr, MD
Phone
01286296939
Ext
002
Email
hosamabuelnasr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed al hefnawy, MD
Phone
01003481084
Ext
002
Email
dr.mohamedalhefnawy@gmail.com
Facility Information:
Facility Name
Benha University Hospitals
City
Banhā
State/Province
Qaliopia
ZIP/Postal Code
13518
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hosam abu el-nasr, MD
Phone
01286296939
Ext
002
Email
hosamabuelnasr@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25086164
Citation
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.
Results Reference
result
PubMed Identifier
23727415
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/j.juro.2013.05.062. Epub 2013 May 30.
Results Reference
result
PubMed Identifier
23769122
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 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. Erratum In: Urology. 2013 Dec;82(6):1457.
Results Reference
result
PubMed Identifier
26876327
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.
Results Reference
result
PubMed Identifier
30511212
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. doi: 10.1007/s00345-018-2576-0. Epub 2018 Dec 3.
Results Reference
result
PubMed Identifier
22362256
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 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. Erratum In: Eur J Pediatr. 2012 Jun;171(6):1005. Eur J Pediatr. 2013 Feb;172(2):285.
Results Reference
result
PubMed Identifier
32278657
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 Pediatr Urol. 2020 Feb;16(1):10-19. doi: 10.1016/j.jpurol.2019.12.020. Epub 2020 Jan 30.
Results Reference
result

Learn more about this trial

Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis

We'll reach out to this number within 24 hrs