View Clinical Trial (Medical Research Study)

Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP) - NCT00826527-98166(Clinical Trial 265023)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Seattle
State:  
WA
Zip Code: 98166
Conditions: Urinary Frequency - Urinary Urgency - Nocturia
Purpose: 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.
Study summary: 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.
Criteria: 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.
Study is available at: Seattle Urology Research Center
Seattle, WA 98166
United States

Primary Contact:
Angel J Felipa, Coordinator
Email: surc@comcast.net
Phone: 206-243-3701

Secondary Contact:
Angel J Felipa, Coordinator
Email: surc@comcast.net
Phone: 206-243-3701
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.