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Antimuscarinic Agent
Solifenacin for Urinary Symptoms Post-Prostate Surgery
Phase 4
Waitlist Available
Led By Jeffrey M Frankel, MD
Research Sponsored by Seattle Urology Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients may be included if they have previously been treated with FDA approved anticholinergic agents for the treatment of OAB such as Oxybutynin chloride, Tolterodine tartrate, or trospium chloride and are no longer receiving such treatment for a minimum of 14 days prior to study
Male patients greater than 18 years of age with continued OAB symptoms after successful PVP for BPH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will show that the drug solifenacin can help with urinary symptoms after a GreenLight laser surgery that improves obstructive symptoms.
Who is the study for?
Men over 18 with ongoing Overactive Bladder (OAB) symptoms after successful prostate surgery using GreenLight laser can join. They must have stopped any previous OAB treatments like Oxybutynin for at least 14 days. Those with bladder stones, cancer, infections, certain urinary issues, hypersensitivity to Solifenacin or similar drugs, recent trial participation or conditions that may risk safety are excluded.Check my eligibility
What is being tested?
The study is testing if the drug Solifenacin can improve irritative bladder symptoms such as nighttime urination and urgency in men who've had a specific prostate procedure. It's for those whose blockage was cleared but still experience discomfort.See study design
What are the potential side effects?
Solifenacin might cause dry mouth, constipation, blurred vision and dizziness due to its anticholinergic effects. Some people could also experience mild stomach upset or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stopped taking my OAB medication for at least 14 days.
Select...
I am a man over 18 with ongoing bladder issues after prostate surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dysuria
Secondary outcome measures
Change in mean nocturia episodes/24 hours based on 3 day diary
Find a Location
Who is running the clinical trial?
Seattle Urology Research CenterLead Sponsor
Jeffrey M Frankel, MDPrincipal InvestigatorSeattle Urology Research Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a urinary blockage with a maximum flow rate less than 12 milliliters per second when starting the study.You have trouble emptying your bladder, as indicated by a post-void residual (PVR) volume greater than 150 ml.I have a condition where my bladder doesn't empty properly due to nerve problems.I have been diagnosed with a blockage in my digestive tract.I have prostate cancer.I have a long-term inflammation condition.I have had bladder cancer in the past.I have uncontrolled narrow-angle glaucoma.I am taking medication for muscle spasms or bladder control.I have been treated with darifenacin before.I have stopped taking my OAB medication for at least 14 days.I have bladder stones.You are allergic to Solifenacin or other similar medications.I have problems with my stomach emptying.I am a man over 18 with ongoing bladder issues after prostate surgery.I have severe kidney or liver problems.I have a urinary tract infection.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks does this treatment pose for individuals?
"Assuredly, our team at Power assigns this treatment a score of 3 due to the fact that its Phase 4 trial status implies it has been approved."
Answered by AI
Are there currently any opportunities for participants to join this research project?
"Clinicaltrials.gov reports that this clinical trial is no longer recruiting patients; the initial post date was on January 1st 2007 and it most recently updated on January 21st 2009. Alternatively, 15 other trials are currently seeking participants for their respective studies."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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