Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms

Inclusion Criteria: Subjects may be included in the study if they have bladder and/orurethral pain and lower urinary tract storage symptoms and only if they meet all of thefollowing criteria at screening/baseline.

1. Subjects are capable of giving signed informed consent, which includes compliance withthe requirements and restrictions listed in this protocol.
2. Symptomatic subjects with BPS (NIH/NIDDK/MAPP definition) with perceived bladder pain +/- urinary storage symptoms) or symptomatic patients with CCS (chronic UTI definitionbased on modified ACSS with dysuria)
3. Subjects with previous failure of standard urine culture directed therapy approach,eg. antibiotic treatment based on previous urine culture results (positive, sterile,or nebulous) failed to provide appreciable clinical benefit.
4. Subjects who have experienced a minimum of 3 months of continuous symptoms
5. Subjects who have a minimum average daily bladder pain score of ≥ 3 on a 0-10 NRSscale in the past 3 months
6. Subjects with no antibiotic therapy for the previous 2 weeks
7. Subjects with no UTI supplements including cranberry, d-mannose, high dose vitamin Cand Lactobacillus probiotics for the previous 2 weeks.

Exclusion Criteria: Subjects will be excluded from participating in this study if they meetany of the following criteria:

1. Subjects with any of the following confounding conditions: bladder stones, lowerureteric stones, vaginal candidiasis, urethral diverticulum, urinary retention (≥ 300mL), overactive bladder (ie, urinary urgency secondary to urinary incontinence), orany other condition/disease, which, in the opinion of the investigator, couldcompromise patient safety or confound the collection or interpretation of studyresults.
2. Subjects who are pregnant or planning a pregnancy during the study period
3. Subjects with a history of previous urinary diversion procedure with or withoutbladder removal or bladder augmentation.
4. Subjects with a history of bladder cystoscopy only within 1 month or cystoscopy withbladder biopsy, hydrodistension, fulguration or triamcinolone injection or treatmentof Hunner ulcer performed within 3 months prior to Screening.
5. Subjects undergoing active treatment for cancer - urologic (eg bladder) or other -with surgery, radiation or chemotherapy within previous 8 weeks of screening.
6. Subjects with a neurogenic bladder (due to spinal cord injury, stroke, Parkinson'sdisease, multiple sclerosis, spina bifida, or diabetic cystopathy).
7. Subjects with genital herpes active within 3 months prior to screening.
8. Subjects with a history of gross (visible) hematuria within 1 year prior to screeningthat has not been evaluated.
9. Subjects who have had major surgery within the past 3 months or has surgery plannedduring the study period
10. Subjects with a history of alcohol and/or drug abuse that in the investigator'sopinion could interfere with the study evaluations or the patient's safety.
11. Subjects catheterized in the past month
12. Subjects that have received antibiotic treatment based on MicroGenDX's NGS results inthe prior 12 months
13. Subjects with indwelling ureteral stents
14. Subjects that have received a bladder instillation within the last 4 weeks