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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00826527
• Other study ID #: SURC-01-2006
• Status: Recruiting
• Phase: Phase 4
• First received: January 20, 2009
• Last updated: January 21, 2009
• Start date: January 2007

Study information

• Verified date: January 2009
• Source: Seattle Urology Research Center
• Contact: Angel J Felipa, Coordinator
• Phone: 206-243-3701
• Email: surc[@]comcast.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Nocturia
• Urinary Frequency
• Urinary Urgency

Intervention

Drug:
• Solifenacin PO
Tab 5 mg Daily for 12 Weeks

Locations

Country	Name	City	State
United States	Seattle Urology Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Urology Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of micturitions per 24 hours utilizing a 3 day micturition diary		12 weeks	Yes
Secondary	Change in mean nocturia episodes/24 hours based on 3 day diary		12 weeks	Yes