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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Urology Research Center
• Treatments: Solifenacin Succinate

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.