NCT07199894

Brief Summary

The goal of this clinical trial is to compare combination of Solifenacin and MIrabegron in treatment of primary mono-symptomatic nocturnal enuresis in children. It will also learn about the safety of that combination. The main questions it aims to answer are: Does combination of Solifenacin and MIrabegron lower the number of wet nights? What medical problems do participants have when taking combination of Solifenacin and MIrabegron? Researchers will compare the combination to omegapress to see if the combination works better to treat primary mono-symptomatic nocturnal enuresis. Participants will: Take the combination or Omegapress every day for 3 months Visit the clinic once monthly for checkups and tests Keep a diary of their symptoms and the number of wet nights

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

August 18, 2025

Last Update Submit

September 22, 2025

Conditions

Nocturnal Enuresis in Children

Keywords

nocturnal enuresisDesmopressinMirabegronSolifenacinB3 agonistAnti-cholinergicRandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Percentage of improvement in number of wet nights per week

    Counting number of wet nights per week before and after receiving treatment and the resulting percentage will be the primary end point.

    90 days

Secondary Outcomes (1)

  • Number of patients who experienced side effects in response to each treatment.

    90 days

Study Arms (2)

ADH analougue monotherapy

SHAM COMPARATOR

Desmopressin

Drug: Desmopressin (DDAVP)

Anticholinergic and b3 agonist combination

EXPERIMENTAL

Solifenacin and Mirabegron

Drug: Mirabegron (beta3-adrenoceptor agonist), Anticholinergics

Interventions

Mirabegron (beta3-adrenoceptor agonist), AnticholinergicsDRUG

Anticholinergic and B3 agonist drugs used for treatment of mono-symptomatic nocturnal enuresis

Anticholinergic and b3 agonist combination
Desmopressin (DDAVP)DRUG

ADH analogue in treatment of mono-symptomatic nocturnal enuresis

ADH analougue monotherapy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary mono-symptomatic nocturnal enuresis -

You may not qualify if:

  • Bowel dysfunction Psychatric illness Respiratory sleep disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology center - Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

mirabegronCholinergic AntagonistsDeamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cholinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsArginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

Abdelhamid El Sayed Shahin, MBBCH

CONTACT

+201005876463hameedshahin95@gmail.com

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
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 30, 2025

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)