Efficacy of Mirabegron for Treatment of Non-monosymptomat... | NCT07398261

Studies
Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children

NCT07398261

Sponsor

Menoufia University

Status

Active, not recruiting

Last Update Posted

Feb 9, 2026Actual

Enrollment

151Estimated

Phase

Phase 3

Conditions

Treatment of Non-monosymptomatic Nocturnal Enuresis

Interventions

Mirabegron 25 MG

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2023Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Aug 29, 2023

First Submission Date that Met QC Criteria

Feb 4, 2026

First Posted Date

Feb 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This phase 3 clinical trial will compare use of individual treatment with mirabegron or desmopressin and their combination for treatment of non-monosymptomatic nocturnal enuresis in children

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

151Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mirabegron 25 mg	Active Comparator	Patients received mirabegron 25 mg orally	Drug: Mirabegron 25 MG
no intervention	No Intervention	no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mirabegron 25 MG	Drug	Evaluate the efficacy of individual mirabegron or in combination for treatment of non-monosymptomatic nocturnal enuresis in children	Mirabegron 25 mg

Measure	Description	Time Frame
Partial or complete response		18 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Non-monosymptomatic nocturnal enuresis

Exclusion Criteria:

monosymptomatic nocturnal enuresis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Menoufia faculty of medicine		Shibīn al Kawm	Monufia Governorate	32616	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 11, 2024	Jan 28, 2026	Prot_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
C520025	mirabegron
C000608232	N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided