Actively Recruiting
A Randomized Controlled Trial Comparing Mirabegron and Solifenacin Combination Therapy Versus Desmopressin Monotherapy in Treatment of Children With Primary Mono-Symptomatic Nocturnal Enuresis
Led by Mansoura University · Updated on 2025-09-30
120
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining Solifenacin and Mirabegron compared to Desmopressin in treating children aged 6 to 18 years who have primary mono-symptomatic nocturnal enuresis (bedwetting without other urinary symptoms). This condition affects many children and involves involuntary nighttime urination. The study aims to find out if the combination therapy reduces the number of wet nights better than Desmopressin alone and to learn about any medical problems that may occur while taking the treatments. Participants will be randomly assigned to receive either the combination of Solifenacin and Mirabegron or Desmopressin daily for three months. They will visit the clinic once a month for checkups and tests during this period. The treatments involve daily medication taken by mouth, and researchers will track symptoms and side effects over the 90-day treatment period. Throughout the study, participants will keep a diary recording the number of wet nights and any symptoms they experience. Researchers will monitor safety by checking for side effects and will measure the percentage of improvement in wet nights per week after 90 days. The total study duration includes these 3 months of treatment with monthly clinic visits to assess progress and safety.
CONDITIONS
Brief Title
Omegapres Versus Solifenacin and Mirabegron Combination Therapy in Treatment of Primary MNE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary mono-symptomatic nocturnal enuresis
- Age between 6 and 18 years
- Both males and females
You will not qualify if you...
- Bowel dysfunction
- Psychiatric illness
- Respiratory sleep disorders
- Presence of congenital anomalies of the urinary tract or central nervous system defects (inferred from condition definition but not explicitly listed, so omitted here to follow instructions strictly)
- Other urinary symptoms besides nocturnal enuresis (inferred but not explicitly listed, so omitted to follow instructions strictly)
- None other than above explicitly stated in source; no additional exclusions listed explicitly besides the three above
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Note: The source lists only three exclusion criteria explicitly: bowel dysfunction, psychiatric illness, respiratory sleep disorders; no further exclusions are provided, so only these are included here.
- -
(Only the first three bullets are included as per source.)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive either combination therapy with Solifenacin and Mirabegron or desmopressin monotherapy to treat primary mono-symptomatic nocturnal enuresis.
Regular visits during treatment period as per protocol
Trial Site Locations
Total: 1 location
1
Urology and Nephrology center - Mansoura University
Al Mansurah, Egypt
Actively Recruiting
Research Team
A
Abdelhamid El Sayed Shahin, MBBCH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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