Cystoscopic Ablation Via RF Energy Clinical Trial (CARET 2)

The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB).
Subjects who are found to be unresponsive to or intolerant of medical therapy will be
screened and evaluated for suitability for study participation. A 3 day Bladder Diary must
be completed to verify enrollment eligibility.

Subjects must meet ALL the inclusion criteria to be eligible to participate

1. Non-pregnant, non-lactating female at least 18 years old with a history of idiopathic
OAB for ≥ 6 months

2. Have failed or are not a candidate for drug treatment

3. Subject is willing to provide Informed Consent, is geographically stable, understands
the requirements for completing the bladder diary and is willing to comply with the
required diary, follow up visit and testing schedules

4. Ambulatory without the aid of walking assistance a majority of the time (cane, walker
etc.) and able to use toilet without assistance

5. Post-void residual (PVR) ≤ 100 ml NOTE: Subjects with a single PVR of >100 ml
followed by two consecutive PVR measurements of ≤100 ml may be included in the study.

6. Ability and willingness to self-catheterize in case this is necessary

7. Bladder Diary Criteria: over the 3 days the following outcomes:

- Micturition frequency of ≥ 8 times/day, on average

- AND > 3 episodes of urgency urinary incontinence (UUI)

Subjects will be excluded if ANY of the following conditions apply:

1. Planning on becoming pregnant during the 18 month study period

2. Current participation in any other conflicting interventional or OAB treatment study

3. Primary complaint of stress urinary incontinence or stress predominant mixed
incontinence or functional incontinence

4. Any invasive or surgical intervention involving the bladder, rectum or vaginal wall
(e.g., radio frequency, implant, sling) within the last 6 months

5. Ongoing complications of prior anti-incontinence surgery

6. SNS or PTNS treatment within the last 15 days. NOTE: a SNS device that is not turned
on is acceptable for enrollment

7. Botox treatment for OAB with 100u in the last 6 months OR Botox treatment with >100u
in last 9 months.

8. Subject with 24-hour total urine volume voided greater than 3,000 ml as measured at
screening period

9. Urinary tract infection that is not resolved at the time of enrollment or had > 3
urinary tract infections (UTIs) within the last 12 months NOTE: If UTI is present at
baseline screening, treatment with antibiotics and a negative urinalysis at least 7
days after the initial diagnosis of UTI will be acceptable for enrollment.

10. Documented spontaneous unprovoked urinary retention within the last 6 months

11. Anatomical conditions or surgical implants that, in the opinion of the investigator,
would preclude the introduction and/or use of the device such as significant pelvic
organ prolapse, urogenital prolapse visible at rest beyond the hymen, significant
cystocele prolapse, implanted vaginal mesh between the trigone of the bladder and
vagina or high BMI.

12. Current hydronephrosis or hydroureter

13. Current bleeding disorder or coagulopathies

14. Current use of antimuscarinics, β3 agonist or antispasmodics NOTE: subjects on these
drugs must undergo a 2 week washout period prior to completing the baseline Bladder
Diary.

15. Subject has been previously diagnosed with bladder cancer or has a current diagnosis
of interstitial cystitis or chronic pelvic pain syndrome.

16. Previous pelvic irradiation

17. Serum creatinine or BUN > twice the upper limit of normal within the last sixty days

18. Neurological disease affecting bladder function such as multiple sclerosis, spinal
cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease

19. Bladder outflow obstruction

20. Ureteral dysfunction, stricture or reflux