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

Nocturia Clinical Trial

Official title: Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)for the Treatment of Clinically Significant Benign Prostate Hyperplasia (BPH)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia
• Urinary Frequency
• Urinary Urgency

• NCT number: NCT00826527
• Study type: Interventional
• Source: Seattle Urology Research Center
• Contact: Angel J Felipa, Coordinator
• Phone: 206-243-3701
• Email: surc@comcast.net
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2007