An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia

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.

Patients will be selected by the investigator and sub-investigator's patient population,
and physician referrals. All patients will meet the inclusion/ exclusion criteria.

Inclusion Criteria

1. Male ≥40 years of age

2. Clinical signs and symptoms of frequency and urgency, enlarged prostate and urodynamic
study consistent with overactive bladder.

3. IPSS >12, with IPSS QoL > 3 at screening visit.

4. Ability and willingness to correctly complete the micturition diary and all the trial
related questionnaires comply with scheduled visits and comply with trial procedures.

5. Capability of understanding and having signed the informed consent form after full
discussion of the research, nature of the treatment, and its risks and benefits.

6. Procedure to treat BOO by TURP or PVP greater than or equal to 1 month ago.

Exclusion Criteria

1. A known history of interstitial cystitis, uninvestigated hematuria, or bladder outlet
obstruction due to: mullerian duct cysts, urethral obstruction due to
stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary
tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.

2. Evidence of Urinary Tract Infection according to local standard of care.

3. Expectation of initiating treatment during the duration of this study with - any drug
treatment for OAB, any drugs with significant anticholinergic, antispasmodic,
parasympathetic, or cholinergic agonistic effects.

4. Use of any electrostimulation within the 30 days before randomization, or the
expectation to initiate such therapy during the study.

5. Any condition which, in the opinion of the investigator, makes the patient unstable,
or with contraindications for inclusion, e.g., uncontrolled narrow-angled glaucoma,
urinary retention, preplanned prostate surgery, or gastric retention.

6. Significant hepatic or renal disease, defined as twice the upper limit of the
reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or
creatinine.

7. Use of any other investigational drug in the 2 months preceding visit 1.

8. History of postural hypotension or syncope in the judgement of the investigator based
on local standards of care.

9. Alcohol and/or any other drug abuse in the opinion of the investigator.

10. Medications such as erythromycin, Biaxin (Clarithromycin), Sporanox (itraconazole),
Nizoral (ketoconazole), Neoral and Sandimmune (cyclosporine), Velban (vinblastine) and
miconazole.

11. Non-medication treatments such as bio-feedback or other bladder training exercises.