- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00826527
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
January 21, 2009 updated by: Seattle Urology Research Center
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)
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
23
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Angel J Felipa, Coordinator
- Phone Number: 206-243-3701
- Email: surc@comcast.net
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98166
- Recruiting
- Seattle Urology Research Center
-
Contact:
- Angel J Felipa, Coordinator
- Phone Number: 206-243-3701
- Email: surc@comcast.net
-
Principal Investigator:
- Jeffrey M Frankel, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean nocturia episodes/24 hours based on 3 day diary
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey M Frankel, MD, Seattle Urology Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
January 20, 2009
First Submitted That Met QC Criteria
January 21, 2009
First Posted (Estimate)
January 22, 2009
Study Record Updates
Last Update Posted (Estimate)
January 22, 2009
Last Update Submitted That Met QC Criteria
January 21, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SURC-01-2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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