Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
The purpose of this study is to demonstrate that solifenacin post-operatively improves
 irritative symptoms in men whose obstructive symptoms have been relieved with the GreenLight
 laser outpatient procedure.
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.