NCT07398261

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P25-P50 for phase_3

Timeline
3mo left

Started Aug 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Aug 2023Nov 2026

Study Start

First participant enrolled

August 28, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

August 29, 2023

Last Update Submit

February 4, 2026

Conditions

Treatment of Non-monosymptomatic Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

  • Partial or complete response

    18 months

Study Arms (2)

Mirabegron 25 mg

ACTIVE COMPARATOR

Patients received mirabegron 25 mg orally

Drug: Mirabegron 25 MG

no intervention

NO INTERVENTION

no intervention

Interventions

Mirabegron 25 MGDRUG

Evaluate the efficacy of individual mirabegron or in combination for treatment of non-monosymptomatic nocturnal enuresis in children

Also known as: vibegron
Mirabegron 25 mg

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Non-monosymptomatic nocturnal enuresis

You may not qualify if:

  • monosymptomatic nocturnal enuresis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia faculty of medicine

Shibīn al Kawm, Monufia Governorate, 32616, Egypt

Location

MeSH Terms

Interventions

mirabegronN-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of urology

Study Record Dates

First Submitted

August 29, 2023

First Posted

February 9, 2026

Study Start

August 28, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)