In short
Clinical trials are studying Solifenacin Succinate in people with daytime urinary incontinence and overactive bladder. These studies look at treatment response, recurrence after stopping treatment, and how different stopping plans compare. The target groups include children aged 5 to 14 years and other patients with daytime urinary incontinence.
Key points
- Clinical trials of Solifenacin Succinate are studying daytime urinary incontinence and overactive bladder. Both trials are Phase 3 studies, which means they are testing the treatment in larger groups of patients. One trial looks at children aged 5 to 14 years and compares Solifenacin Succinate with mirabegron, alone or in combination. The other trial studies what happens when treatment is stopped, comparing abrupt withdrawal with phased withdrawal. The main outcomes are treatment response, measured by wet days, and recurrence of incontinence after withdrawal.
Trial overview
Two authorised Phase 3 trials are studying Solifenacin Succinate for bladder control problems in children and other patients with daytime urinary incontinence.
The trials are called StayDry and BeDry, and both are interventional studies, which means the researchers give treatment and then measure the results.
Who is being studied
The StayDry trial includes people with daytime urinary incontinence and follows them after treatment withdrawal.
The BeDry trial studies children aged 5 to 14 years with daytime urinary incontinence and overactive bladder.
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.
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.
The trial measures this using a 14-day calendar of incontinence episodes, which helps show whether symptoms return after withdrawal.
In BeDry, the main outcome is treatment response, based on the change in the number of wet days over a 12-week treatment period.
A response means a 50% to 100% decrease in wet days, while non-response means less than a 50% decrease.
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.
The same trial involves treatment with Solifenacin and/or mirabegron before withdrawal, so it is focused on how stopping treatment affects return of symptoms.
BeDry compares Solifenacin, mirabegron, and combination therapy with Solifenacin and mirabegron in children.
This makes the study useful for learning whether one treatment works better than another for reducing wet days in young patients.
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.
Both studies are listed as Authorised, and their enrollment numbers are 216 for StayDry and 236 for BeDry.
Patient-friendly terms
Incontinence means leaking urine when you do not want to.
Overactive bladder is a bladder problem that can make it hard to control urination and may lead to leakage.
Wet days are days when urine leakage happens, and researchers use this to measure improvement.
Withdrawal means stopping treatment, and the studies look at whether symptoms come back after that.