This trial is examining the safety and effectiveness of BOTOX used to treat OAB symptoms. The main outcome of the trial to be measured is a change in the number of urinary incontinence (leakage of urine) episodes after 12 weeks.
The details
Urinary incontinence is a common problem that can affect people of all ages. It is often caused by OAB. BOTOX can be used to help relax the bladder muscles and reduce leakage of urine.
This trial is examining the safety and effectiveness of this treatment. It will measure the amount of urinary incontinence after 12 weeks. It will do this by asking participants to keep a 3-day bladder diary.
Who are they looking for?
This study is recruiting 335 patients with symptoms of OAB for the past 6 months. These include increase in number of times of bladder emptying per day (frequency) and the feeling of needing to pass urine (urgency).
Patients should not have OAB caused by a neurological condition, stress incontinence (leaking urine when straining), pelvic problems, or previously had BOTOX treatment for OAB.
How will it work
There will be 8 groups. Four groups will receive differing doses of BOTOX treatment, and four will receive a placebo (a substance with no active effect, used to compare against BOTOX). Neither the researchernor the participant will know who gets each treatment (double-blind). BOTOX or placebo will be injected into the participant’s bladder.
Patients will be followed for up to 24 weeks (6 months).
