Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
Primary Purpose
Urinary Frequency, Urinary Urgency, Nocturia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Solifenacin PO
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Frequency
Eligibility 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.
Sites / Locations
- Seattle Urology Research CenterRecruiting
Outcomes
Primary Outcome Measures
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
Secondary Outcome Measures
Change in mean nocturia episodes/24 hours based on 3 day diary
Full Information
NCT ID
NCT00826527
First Posted
January 20, 2009
Last Updated
January 21, 2009
Sponsor
Seattle Urology Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00826527
Brief Title
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Seattle Urology Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Frequency, Urinary Urgency, Nocturia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Solifenacin PO
Intervention Description
Tab 5 mg Daily for 12 Weeks
Primary Outcome Measure Information:
Title
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in mean nocturia episodes/24 hours based on 3 day diary
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angel J Felipa, Coordinator
Phone
206-243-3701
Email
surc@comcast.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Frankel, MD
Organizational Affiliation
Seattle Urology Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Urology Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel J Felipa, Coordinator
Phone
206-243-3701
Email
surc@comcast.net
First Name & Middle Initial & Last Name & Degree
Jeffrey M Frankel, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
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