Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder. (NCT07391878) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.
Israel60 participantsStarted 2026-02-15
Plain-language summary
This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide written informed consent and comply with all study procedures.
. Male or female adults aged 18 years or older.
. Documented diagnosis of overactive bladder (OAB) for more than 6 months, refractory or intolerant to oral anticholinergic or other OAB therapies.
. Ability to perform and tolerate urethral catheterization for intravesical instillation.
. Meets the following criteria based on the 3-day voiding diary completed at both the Run-in and Baseline visits:
. Average of ≥8 micturitions per day, and
. Average of ≥3 urgency episodes per day, and
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Average Number of Micturitions per 24 Hours
Timeframe: Baseline to Week 12
2
Change From Baseline in Average Number of Urgency Episodes per 24 Hours
Timeframe: Baseline to Week 12
3
Change From Baseline in Average Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours
. Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.
. Known contraindication, hypersensitivity, or allergy to oxybutynin or other anticholinergic agents.
. History of 24-hour urine volume \>3,000 mL.
. Active urinary tract infection or genitourinary infection at screening (re-screening allowed once after treatment).
. Lower urinary tract pathology that may account for symptoms, including but not limited to:
. Structural abnormalities of the bladder (e.g., diverticula, stones) or urogenital anatomical defects.
. History of bladder tumors or prostate cancer within the past 5 years, or history of non-muscle invasive bladder cancer (low-grade) within the past 5 years.
. Ongoing or planned treatment for urologic or gynecologic malignancy.