A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosis of overactive bladder with symptoms for at least 6 months.
- Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
- Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception
Exclusion criteria
- Conditions or prior treatment that may also affect bladder function
- Clinically significant urinary tract infection (UTI)
- Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
Trial design
Primary purpose
Allocation
Interventional model
Masking
990 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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