Table of Contents
- Trial overview
- Who is being studied
- What the trials measure
- Treatments being compared
- Trial phases and status
- Patient-friendly terms
Trial overview
Two authorised Phase 3 trials are studying Solifenacin Succinate for bladder control problems in children and other patients with daytime urinary incontinence.[1][1]
The trials are called StayDry and BeDry, and both are interventional studies, which means the researchers give treatment and then measure the results.[1][1]
Who is being studied
The StayDry trial includes people with daytime urinary incontinence and follows them after treatment withdrawal.[1]
The BeDry trial studies children aged 5 to 14 years with daytime urinary incontinence and overactive bladder.[1]
This means the trials focus on patients who have trouble staying dry during the day, and one of the trials is specifically designed for children.[1][1]
What the trials measure
In StayDry, the main outcome is recurrence of incontinence after treatment is stopped, with follow-up for up to 12 months.[1]
The trial measures this using a 14-day calendar of incontinence episodes, which helps show whether symptoms return after withdrawal.[1]
In BeDry, the main outcome is treatment response, based on the change in the number of wet days over a 12-week treatment period.[1]
A response means a 50% to 100% decrease in wet days, while non-response means less than a 50% decrease.[1]
Treatments being compared
StayDry studies what happens with abrupt withdrawal versus phased withdrawal of pharmacotherapy, which means stopping treatment all at once or step by step.[1]
The same trial involves treatment with Solifenacin and/or mirabegron before withdrawal, so it is focused on how stopping treatment affects return of symptoms.[1]
BeDry compares Solifenacin, mirabegron, and combination therapy with Solifenacin and mirabegron in children.[1]
This makes the study useful for learning whether one treatment works better than another for reducing wet days in young patients.[1]
Trial phases and status
Both trials are in Phase 3, which is a later stage of clinical research used to test how well a treatment works in larger groups.[1][1]
Both studies are listed as Authorised, and their enrollment numbers are 216 for StayDry and 236 for BeDry.[1][1]
Patient-friendly terms
Incontinence means leaking urine when you do not want to.[1][1]
Overactive bladder is a bladder problem that can make it hard to control urination and may lead to leakage.[1]
Wet days are days when urine leakage happens, and researchers use this to measure improvement.[1]
Withdrawal means stopping treatment, and the studies look at whether symptoms come back after that.[1]
