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

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

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.

11. History of recurrent symptomatic urinary tract infections (UTIs) (>4 per 1 year).

12. Subjects with either urinary retention or gastric retention or uncontrolled
narrow-angle glaucoma.

13. A post-void residual volume (PVR) of 300 mL or greater

14. Subjects with known hypersensitivity to trospium, chemically-related drugs, or
component excipients.

15. Subjects with known hypersensitivity to the device materials, including silicone and
nitinol.

16. Subjects actively taking oral trospium.

17. The addition of a new or a change in dose to a current medication for the treatment of
OAB (i.e. anticholinergics, beta-3 adrenergic agonists, antispasmodics,
antidepressants, or hormones) within 30 days prior to signing the informed consent
form (ICF). A stable dose must continue through the final study visit. If previously
used and discontinued, these medications must have been stopped for >2 weeks prior to
Day 0.

18. Intravesical onabotulinum toxin use within the last 9 months prior to the Screening
Visit.

19. Intravesical anticholinergic medications within the last 30 days prior to the
Screening Visit.

20. History of non-medication based therapy (i.e. InterStim therapy) for the treatment of
OAB. History of non-invasive neuromodulation (i.e. Percutaneous Tibial Nerve
Stimulation (PTNS)) is allowed if discontinued at least 8 weeks prior to Study Day 0.

21. Female subject who is pregnant (as verified by urine test at time of screening) or
lactating or of childbearing potential and not using acceptable methods of
contraception.

22. Subject has a medical condition that may cause noncompliance with the study protocol.

23. Subject refuses to provide written informed consent.

24. Subject will be unable or unwilling to complete the questionnaires, diaries, or attend
all protocol mandated study visits.

25. Participation in another drug, device, or behavioral study within 60 days prior to the
Screening Visit.

26. History or presence of any significant cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, gynecological, endocrine, immunological, dermatological,
neurological or psychiatric disease or disorder that, in the opinion of the
investigator, contraindicates participation.

27. History of any of the following within 3 months prior to Screening Visit:

- Major illness/major surgery (requiring hospitalization), including pelvic, lower
back surgery or procedure unrelated to bladder cancer; most outpatient procedures
are not exclusionary

- Renal or ureteral stone disease or instrumentation

- Childbirth

28. Difficulty providing blood samples.

29. Other unspecified reasons that, in the opinion of the investigator or TARIS, make the
subject unsuitable for enrollment.