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

NCT07391878 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: TRGC-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder (OAB)

Keywords

Refractory Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Average Number of Micturitions per 24 Hours

  Change from baseline in the average number of micturitions per 24 hours, as recorded in a 3-day patient voiding diary.

  Baseline to Week 12

• Change From Baseline in Average Number of Urgency Episodes per 24 Hours

  Change from baseline in the average number of urgency episodes (defined as a sudden and compelling desire to void) per 24 hours, based on the 3-day patient voiding diary.

  Baseline to Week 12

• Change From Baseline in Average Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours

  Change from baseline in the average number of urgency urinary incontinence (UUI) episodes per 24 hours, as recorded in the 3-day patient voiding diary.

  Baseline to Week 12

Secondary Outcomes (11)

• Proportion of Participants With ≥50% Reduction in Micturitions per 24 Hours

  Baseline to Week 12

• Proportion of Participants With ≥50% Reduction in Urgency Episodes per 24 Hours

  Baseline to Week 12

• Proportion of Participants With ≥50% Reduction in Urgency Urinary Incontinence (UUI) Episodes

  Baseline to Week 12

• Change From Baseline in Nocturnal Voids per Night

  Baseline to Week 12

• Change From Baseline in Average Voided Volume

  Baseline to Week 12

Study Arms (2)

TRG-200 KIT - 150 mg (Dose-Evaluation Cohort)

EXPERIMENTAL

Participants receive intravesical administration of TRG-200 KIT containing oxybutynin 150 mg. The investigational product is administered via intravesical instillation following a single-blind placebo run-in period. This arm is part of the initial dose-evaluation stage to assess safety, tolerability, and preliminary efficacy.

Drug: TRG-200 KIT

TRG-200 KIT - 300 mg (Dose-Evaluation Cohort)

EXPERIMENTAL

Participants receive intravesical administration of TRG-200 KIT containing oxybutynin 300 mg. The investigational product is administered via intravesical instillation following a single-blind placebo run-in period. This arm is part of the initial dose-evaluation stage to assess safety, tolerability, and preliminary efficacy.

Drug: TRG-200 KIT

Interventions

TRG-200 KIT DRUG

TRG-200 KIT is administered intravesically as a sustained-release formulation. The investigational product consists of a Carbopol gel matrix followed by intravesical instillation of oxybutynin via a urethral catheter, forming a prolonged-release delivery system within the bladder. The intervention is designed to provide sustained local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.

TRG-200 KIT - 150 mg (Dose-Evaluation Cohort); TRG-200 KIT - 300 mg (Dose-Evaluation Cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• OAB is defined as urinary urgency, usually accompanied by frequency and/or nocturia, with or without urgency urinary incontinence.
• 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.
• Post-void residual (PVR) urine volume \<150 mL.
• Negative urine culture at screening.
• Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use effective contraception throughout the study.
• Stable medical condition, without acute illness, as determined by the investigator.
• Demonstrated ability to complete the 3-day voiding diary as reviewed at the Run-in and Baseline visits.

You may not qualify if:

• 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:
• 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.
• 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.
• Requirement for indwelling catheter or clean intermittent catheterization (CIC), implanted nerve stimulator, or prior procedures affecting bladder function.
• Renal insufficiency or serum creatinine \>1.5 times the upper limit of normal, or patients on dialysis.
• Recent pelvic surgery or pelvic radiation within the past 6 months.
• Neurological conditions affecting bladder function or contraindicating catheterization.
• Alcohol or drug abuse.
• Uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Trigone Pharma Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hila Kfir

CONTACT

+972-523313350; hila.k@trigonepharma.com

Avi Gordon

CONTACT

+972-524402662; avi.g@trigonepharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is primarily open-label. A short single-blind placebo run-in period is conducted prior to treatment initiation, during which participants are blinded to the placebo instillation. Investigators are aware of the treatment administered. All subsequent treatment phases are open-label, with no masking applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, parallel-assignment study with two experimental dose-evaluation arms (150 mg and 300 mg). An adaptive two-stage design is used for dose selection, followed by expansion with the selected dose.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 6, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

IL (1)