Health TrialsbyHealthPanel

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)

ConditionUrinary Incontinence in Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-14
SponsorUniversity of Aarhus

About this trial

The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.

In total, 236 children diagnosed with daytime urinary incontinence will be randomized 1:1:1:1 to one of four treatment groups. Total pharmacological treatment period will be 18 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.

Age 5 to 14 years (inclusive) at the time of inclusion.

Overactive bladder as per International Children's Continence Society criteria

At least 2 daytime urinary incontinence episodes per week

Disqualifiers

Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information

Known or suspected hypersensitivity to study medication

Any contraindication to the use of the study medication

Known urogenital anatomical abnormalities affecting lower urinary tract function

Trial design

Design model

Parallel

Treatments tested in this trial

  • Solifenacin

    Drug

    According to randomization.

  • Mirabegron

    Drug

    According to randomization.

Treatment groups

236 Participants
are divided into 4 treatment groups
Group A: Solifenacin 5 mg + add-on solifenacin 5 mgExperimental treatment 1 intervention
Group B: Solifenacin 5 mg + add-on mirabegron 25 mgExperimental treatment 2 interventions
Group C: Mirabegron 25 mg + ad-on mirabegron 25 mgExperimental treatment 1 intervention
Group D: Mirabegron 25 mg + add-on solifenacin 5 mgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Treatment response

Assesed by change in number of wetdays pr. 7 days by DryPie

Time frame
From study week 6 and through study completion, an average of 18 weeks in total

Secondary outcomes

1

Treatment response

Assesed by change in number of wetdays pr. 7 days by DryPie

Time frame
From date of randomization until study completion, an average of 18 weeks in total
2

Inconcintnence severity score

Assesed by DryPie (scoring from 0 to 21, in which the higher score means severe incontinence)

Time frame
From date of randomization until study completion, an average of 18 weeks in total
3

Urge severity

Quantified by Bower VAS Urgency Scheme (scoring from 0 to 10, in which the higher score means servere urge)

Time frame
From date of randomization until study completion, an average of 18 weeks in total
4

Maximum voided volume (ml)

48-hour frequency-volume chart

Time frame
From date of randomization until study completion, an average of 18 weeks in total

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Source ClinicalTrials.gov
Apply now