Loading clinical trials...

Safety and Tolerability of TAR-302-5018 in Subjects With Idiopathic Overactive Bladder | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Tolerability of TAR-302-5018 in Subjects With Idiopathic Overactive Bladder

A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Subjects With Idiopathic Overactive Bladder (iOAB) and Urinary Incontinence

NCT03109379•Taris Biomedical LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with idiopathic overactive bladder and urinary incontinence.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Symptoms of overactive bladder (OAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months
•* 8 or more voids per 24 hours as recorded in a diary
•* At least 4 incontinence episodes associated with urgency recorded in a 3-day diary.
•* At least 1 episode must occur per each 24 hour day
•2. Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
•1. Symptoms of idiopathic overactive bladder (iOAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months.
•* 8 or more voids per 24 hours as recorded in a diary
•* At least 4 incontinence episodes associated with urgency recorded in a 3-day diary.
•1. At least 1 episode must occur per each 24 hour day
•2. In the opinion of the investigator, the subject has experienced an inadequate response to or limiting side effects with prior oral medications for the treatment of OAB.

Exclusion Criteria

•1. Age \<18 years.
•2. OAB caused by neurological condition.
•3. Presence of significant renal dysfunction at screening (Glomerular Filtration Rate \<30 mL/min).
•4. Presence of significant polyuria of any cause at screening (urine output \>4,000 mL/day).
•5. History of pelvic radiation.
•6. History of either bladder cancer or bladder pathology that the investigator deems unfit for study inclusion.
•7. Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
•8. Subjects with any bladder or urethral anatomic feature that may prevent the safe placement, indwelling use, or removal of TAR 302 5018.
•9. In the opinion of the investigator, the subject has a history of significant stress urinary incontinence.
•10. Subjects with active bladder stones or history of bladder stones \<6 months prior to study entry.
+57 more criteria

Locations (12)

Urological Associates of Southern Arizona

Tucson, Arizona, United States

Medical Center for Clinical Research

San Diego, California, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

DelRicht Clinical Research, LLC

New Orleans, Louisiana, United States

Bay State Clinical Trials, Inc

Watertown, Massachusetts, United States

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Michigan Institute of Urology

Troy, Michigan, United States

New Jersey Urology

Voorhees Township, New Jersey, United States

Accumed Research

Garden City, New York, United States

Manhattan Medical Resear

New York, New York, United States

Key Dates

Start Date

April 4, 2017

Primary Completion Date

September 27, 2019

Completion Date

September 27, 2019

Last Updated

January 13, 2020

Enrollment

ACTUAL participants

Conditions

Idiopathic Overactive Bladder With Urinary Incontinence

Interventions

Trospium-Releasing Intravesical System (TAR-302-5018)

DRUG