Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.

Exclusion Criteria

• •1. Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.
• •2. Known contraindication, hypersensitivity, or allergy to oxybutynin or other anticholinergic agents.
• •3. History of 24-hour urine volume \>3,000 mL.
• •4. Active urinary tract infection or genitourinary infection at screening (re-screening allowed once after treatment).
• •5. Lower urinary tract pathology that may account for symptoms, including but not limited to:
• •urethral diverticulum, radiation cystitis, tuberculosis cystitis, neurogenic bladder, vaginal candidiasis, urolithiasis, interstitial cystitis, urothelial tumor, clinically significant benign prostatic hyperplasia with obstruction, bladder outlet obstruction, prostatitis, prostate or gastrointestinal cancer.
• •6. Structural abnormalities of the bladder (e.g., diverticula, stones) or urogenital anatomical defects.
• •7. 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.
• •8. Ongoing or planned treatment for urologic or gynecologic malignancy.
• •9. Requirement for indwelling catheter or clean intermittent catheterization (CIC), implanted nerve stimulator, or prior procedures affecting bladder function.
• •10. Renal insufficiency or serum creatinine \>1.5 times the upper limit of normal, or patients on dialysis.
• •11. Recent pelvic surgery or pelvic radiation within the past 6 months.
• •12. Neurological conditions affecting bladder function or contraindicating catheterization.
• •13. Alcohol or drug abuse.
• •14. Uncontrolled diabetes mellitus.
• •15. Hemodynamic instability, including abnormal heart rate, respiratory rate, blood pressure, or oxygen saturation outside protocol-defined ranges.
• •16. Unstable cardiovascular disorders, including but not limited to myocardial infarction, ischemic heart disease, atrial fibrillation, heart block, Wolff-Parkinson-White syndrome, bradycardia, coronary artery disease, or QT prolongation.
• •17. History of significant liver dysfunction, gastrointestinal bleeding, renal disease, seizures, inflammatory bowel disease, or hepatitis.
• •18. Clinically significant hematologic abnormalities, including leukopenia, thrombocytopenia, or anemia below protocol-defined thresholds.
• •19. Body mass index (BMI) ≥40 kg/m².
• •20. Any medical condition that, in the investigator's opinion, may place the participant at increased risk, confound study results, or interfere with study conduct.
• •21. Recent changes (within 8 weeks) in lower urinary tract interventions, including neuromodulation, tibial nerve stimulation, pelvic floor muscle training, or biofeedback.
• •22. Lifetime history of psychotic or bipolar disorder.
• •23. Active genital herpes or vaginitis.
• •24. Women with urinary symptoms occurring exclusively during menstruation.
• •25. Participation in another interventional clinical trial within 30 days prior to screening.