Omegapres versus solifenacin plus mirabegron for children with primary mono‑symptomatic nocturnal enuresis
A Randomized Controlled Trial Comparing Mirabegron and Solifenacin Combination Therapy Versus Desmopressin Monotherapy in Treatment of Children With Primary Mono-Symptomatic Nocturnal Enuresis
This tests whether a daily combination of solifenacin and mirabegron reduces nightly bedwetting more than Omegapres in children with primary mono‑symptomatic nocturnal enuresis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT07199894 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Primary mono-symptomatic nocturnal enuresis - Exclusion Criteria: Bowel dysfunction Psychatric illness Respiratory sleep disorders \-
Where this trial is running
Al Mansurah
- Urology and Nephrology center - Mansoura University — Al Mansurah, Egypt (Recruiting)
Study contacts
- Study coordinator: Abdelhamid El Sayed Shahin, MBBCH
- Email: hameedshahin95@gmail.com
- Phone: +201005876463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.