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
Intervention: Toviaz (Fesoterodine)
Intervention description: 4mg to 8mg by mouth once daily
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 40 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BPH; BOO

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.
    

Eligibility criteria:

        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.