Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)

Obstruction of the urinary tract secondary to benign prostatic hyperplasia can result in
both obstructive and irritative urinary symptoms. In the last few years, photovaporization
of the prostate has emerged as a popular teatment for this problem. This outpatient
procedure uses a GeenLight KTP laser manufactured by Laserscope to vaporize the obstructing
aspects of the prostatic urethral tissue to create a central cavity. After obstruction is
relieved , it is not uncommon for a patient to be left with the irritative symptoms of
frequency, urgency and nocturia, either from the procedure itself in the short-term or due
to changes that develop in the bladder due to the long-standing obstruction. Clinical
experience with this procedure indicates that after the mechanical obstruction of the
prostate is relieved, medical therapy with an antimuscarinic agent should be able to
alleviate these irritative urinary symptoms without the risk of urinary retention. By adding
solifenacin in the early post operative period ( 2-12 weeks)for the subset of patients still
experiencing irritative symptoms, further improvements in bladder symptoms my be achieved.

Inclusion Criteria:

- Written informed consent obtained

- Male patients greater than 18 years of age with continued OAB symptoms after
successful PVP for BPH.

- Patients may be included if they have previously been treated with FDA approved
anticholinergic agents for the treatment of OAB such as Oxybutynin chloride(generic
oxybutynin chloride, Ditropan XL, or Oxytrol) Tolterodine tartrate(Detrol or Detrol
LA), or trospium chloride(Santura) and are no longer receiving such treatment for a
minimun of 14 days prior to study

Exclusion Criteria:

- Previous treatment with darifenacin

- Urinary obstruction as defined as a Qmax < 12 ml/sec at time of study entry.

- Urinary retention as defined as PVR > 150 ml

- Neurogenic Bladder

- Prostate Cancer

- Chronic inflammation( i.e. interstitial cystitis)

- Bladder stones

- History of bladder cancer

- Urinary tract infection

- Uncontrolled narrow-angle glaucoma

- Gastric retention

- History of diagnosed gastro-intestinal obstructive disease.

- Severe renal or hepatic impairment

- Concomitant anticholinergic or antispasmodic medications.

- Known or suspected hypersensitivity to Solifenacin, any of its components (lactose
monohydrate, corn starch, hydromellose 2910, magnesium stearate, talc, polyethylene
glycol 8000 ant titanium dioxide with yellow ferric oxide(5 mg tablet) or red ferric
oxide(10 mg tablet, or other anticholinergics.

- Participation in any clinical trial involving an investigational drug, within 30 days
prior to enrollment.

- Any clinical condition, which in the opinion of the investigator, would not allow
safe completion of the study.