Bladder Outlet Obstruction Clinical Trial
Official title:
An Open Label Study to Measure the Efficacy of Fesoterodine (Toviaz) on Continued Detrusor Overactivity in Patients That Have Undergone Treatment for Bladder Outlet Obstruction
The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study.
Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men.
Unfortunately, it does not often resolve after treatment of the obstruction (transurethral
resection of the prostate). These patients are usually started empirically on alpha-blockers
or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and
latter, to treat overactive bladder. We hypothesize that these patients would be
significantly improved with a long-acting anticholinergic agent such as long acting
Fesoterodine or Toviaz.
Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on
symptoms of patients with bladder outlet obstruction and overactive bladder. In addition,
anticholinergic drug Toviaz is not associated with increased incidence of complication like
acute urinary retention, a state where patient is unable to empty the bladder as an adverse
effect of the drug.
A large proportion of our patients that are undergoing treatment for bladder outlet
obstruction also have overactive bladder. We propose an open label trial to evaluate the
efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of
overactive bladder one month following transurethral resection of the prostate. Toviaz is an
antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with
overactive bladder on urodynamic test preoperatively will be considered. If these patients
continue to have symptoms at the one-month post-operative visit, they will be enrolled into
the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will
receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months
post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA
symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void
residual measured by bladder scan. Using standard statistical analysis, we will see if there
is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7
months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and
complications. An FDA approved flexible dosing regimen will be allowed for the duration of
the study.
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