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 range18 Years
SexALL
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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
✓. Average of ≥2 nocturia episodes per night.
Exclusion criteria
✕. Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.
✕
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
. 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.