Omegapres Versus Solifenacin and Mirabegron Combination Therapy in Treatment of Primary MNE

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-18
SponsorMansoura University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirabegron (beta3-adrenoceptor agonist), Anticholinergics

    Drug

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

  • Desmopressin (DDAVP)

    Drug

    ADH analogue in treatment of mono-symptomatic nocturnal enuresis

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ADH analougue monotherapySham comparator 1 intervention
Group B: Anticholinergic and b3 agonist combinationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
90 days

Secondary outcomes

1

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

Each patient will be followed up monthly during the 3 months period and surveyed for side effects. The number of patients who experienced side effects will be compared between the two groups and compare the number of patients who subsequently discontinued the treatment.

Time frame
90 days

Other outcomes

Sponsors and contacts

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