Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 6 to 18

Omegapres versus solifenacin plus mirabegron for children with primary mono‑symptomatic nocturnal enuresis

Official title: A Randomized Controlled Trial Comparing Mirabegron and Solifenacin Combination Therapy Versus Desmopressin Monotherapy in Treatment of Children With Primary Mono-Symptomatic Nocturnal Enuresis

Run by Mansoura University · NCT07199894 · Data updated 2026-11-12

This tests whether a daily combination of solifenacin and mirabegron reduces nightly bedwetting more than Omegapres in children with primary mono‑symptomatic nocturnal enuresis.

More Nocturnal Enuresis in Children trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages6 Years to 18 Years
SexAll
Enrollment120 (estimated)
SponsorMansoura University
Academic / other
Locations1 site (Al Mansurah)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedDecember 1, 2025
Study endsFebruary 1, 2026
Registry record updatedSeptember 30, 2025
Trial IDNCT07199894 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 5 years or older with primary mono‑symptomatic nocturnal enuresis and no other lower urinary tract symptoms are the intended participants.

Probably not a fit

Children with bowel dysfunction, psychiatric illness, respiratory sleep disorders, congenital urinary tract anomalies, or non‑mono‑symptomatic enuresis are unlikely to benefit from this regimen.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children with primary mono‑symptomatic nocturnal enuresis will receive either a daily combination of solifenacin and mirabegron or Omegapres for three months and will be followed monthly. Caregivers will keep a diary of wet nights and symptoms while clinic visits include checks and safety tests. The trial's main outcomes are change in number of wet nights and the safety/tolerability of the drug combination. Participants with bowel dysfunction, psychiatric illness, or respiratory sleep disorders are excluded.

Why it matters

Potential benefit: If successful, the combination could reduce the number of wet nights and provide an alternative for children who do not respond to desmopressin alone.

How similar studies have gone: Smaller studies and off‑label use of anticholinergics and mirabegron have shown benefit for detrusor overactivity and some enuresis cases, but large phase‑3 data combining these two drugs versus desmopressin are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Primary mono-symptomatic nocturnal enuresis -

Exclusion Criteria:

Bowel dysfunction Psychatric illness Respiratory sleep disorders

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Where it's running

  • Urology and Nephrology center - Mansoura University
    Al Mansurah, Egypt
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.