Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedJanuary 22, 2009
January 1, 2009
2.9 years
January 20, 2009
January 21, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
12 weeks
Secondary Outcomes (1)
Change in mean nocturia episodes/24 hours based on 3 day diary
12 weeks
Interventions
Tab 5 mg Daily for 12 Weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seattle Urology Research Center
Seattle, Washington, 98166, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey M Frankel, MD
Seattle Urology Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 22, 2009
Study Start
January 1, 2007
Primary Completion
December 1, 2009
Last Updated
January 22, 2009
Record last verified: 2009-01