BeDry
- Conditions
- Daytime urinary incontinence and overactive bladder
- Registration Number
- 2023-510187-13-00
- Lead Sponsor
- Region Midtjylland
- Brief Summary
The primary objective is to evaluate the effect of solifenacin versus mirabegron versus combination therapy of solifenacin and mirabegron, in treatment of daytime urinary incontinence in children aged 5 to 14 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 236
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation any study specific procedures.
Age 5 to 14 years (inclusive) at the time of signing the consent.
Overactive bladder as per ICCS criteria
At least 2 daytime urinary incontinens episodes per week
Inadequate effect of 4 weeks urotherapy (non-pharmacological treatment)
No previous treatment with solifenacin, mirabegron, intradetrusor botulinum toxin injections
No current constipation as per ROME IV criteria or fecal incontinence (laxative treatment is accepted)
Per investigator’s judgment, the participant can swallow or can learn to swallow study medication
Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information
Inability to swallow study medication
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
Known kidney or bladder stones
Known diabetes insipidus (central or nephrogenic)
Ongoing symptomatic urinary tract infection (dysuria, fever, bacterial growth by urine culturing)
Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment
Known QTc prolongation, QTc >460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)
Female subjects of childbearing potential
Other significant ECG abnormalities
Known hypertension
≤3 daily voiding, evaluated by 48-hour frequency-volume chart
Uroflowmetry suggestive of other pathology than OAB (staccato-shaped, interrupted-shaped, or plateau-shaped curve)
Post-void residual >50 ml after doublet voiding
Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria
Pregnancy or breastfeeding
Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is treatment response as defined by non-response (<50% decrease in number of wet days) and response (50-100% decrease in number of wet days), assessed by a change from visit 2 and across the 12-week pharmacological treatment period. The number of wet days is assessed pr. 7 days by DryPie. The treatment response will be evaluated for solifenacin, mirabegron and combination of solifenacin and mirabegron. The primary outcome measure is treatment response as defined by non-response (<50% decrease in number of wet days) and response (50-100% decrease in number of wet days), assessed by a change from visit 2 and across the 12-week pharmacological treatment period. The number of wet days is assessed pr. 7 days by DryPie. The treatment response will be evaluated for solifenacin, mirabegron and combination of solifenacin and mirabegron.
- Secondary Outcome Measures
Name Time Method Identifications of ECG abnormalities by electrocardiogram Identifications of ECG abnormalities by electrocardiogram
Change in number of wet days pr. 7 days assessed by Dry Pie, baseline to 18 weeks Change in number of wet days pr. 7 days assessed by Dry Pie, baseline to 18 weeks
Change in incontinence severity score pr. 7 days assessed by Dry Pie, baseline to 18 weeks Change in incontinence severity score pr. 7 days assessed by Dry Pie, baseline to 18 weeks
Change in urge severity quantified by Bower VAS Urgency, baseline to 18 weeks Change in urge severity quantified by Bower VAS Urgency, baseline to 18 weeks
Change in maximum volume voided (MVV), baseline to 18 weeks Change in maximum volume voided (MVV), baseline to 18 weeks
Change in age standardized MVV (MVV as a percent of expected bladder capacity (EBC)), baseline to 18 weeks Change in age standardized MVV (MVV as a percent of expected bladder capacity (EBC)), baseline to 18 weeks
Change in average voided volume (AVV), baseline to 18 weeks Change in average voided volume (AVV), baseline to 18 weeks
Change in micturition frequency, baseline to 18 weeks Change in micturition frequency, baseline to 18 weeks
Change in fluid-intake, baseline to 18 weeks Change in fluid-intake, baseline to 18 weeks
Change in maximum flow rate (Qmax) assessed by uroflowmetry, baseline to 18 weeks Change in maximum flow rate (Qmax) assessed by uroflowmetry, baseline to 18 weeks
Change in Pediatric incontinence questionnaire total score, baseline to 18 weeks Change in Pediatric incontinence questionnaire total score, baseline to 18 weeks
Change in WHO-5 total score, baseline to 18 weeks Change in WHO-5 total score, baseline to 18 weeks
Adverse event (AE), serious adverse event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) monitoring Adverse event (AE), serious adverse event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) monitoring
Change in blood pressure and pulse, baseline to 18 weeks Change in blood pressure and pulse, baseline to 18 weeks
Change in ultrasonic assessed post-void residual urine, baseline to 18 weeks Change in ultrasonic assessed post-void residual urine, baseline to 18 weeks
Identification of urinary tract infection by urine dipstick and verified by routine urine cultivation Identification of urinary tract infection by urine dipstick and verified by routine urine cultivation
Treatment response of solifenacin, mirabegron and combination of solifenacin and mirabegron, baseline across 18 week treatment period Treatment response of solifenacin, mirabegron and combination of solifenacin and mirabegron, baseline across 18 week treatment period
Trial Locations
- Locations (4)
Kolding Sygehus
🇩🇰Kolding, Denmark
Esbjerg Sygehus
🇩🇰Esbjerg, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Region Midtjylland
🇩🇰Herning, Denmark
Kolding Sygehus🇩🇰Kolding, DenmarkLouise WindingSite contact76362203louise.winding1@rsyd.dk