An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia
Condition: Bladder Outlet Obstruction
MeSH terms: Urinary Bladder Neck Obstruction
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Toviaz (Fesoterodine)
Intervention type(s): Drug
Intervention description(s): 4mg to 8mg by mouth once daily
Other intervention name(s): Toviaz
Intervention MeSH terms: Fesoterodine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BPH; BOO