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

Eligibility Criteria

• 1. Subjects are capable of giving signed informed consent, which includes compliance with the 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 definition based 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 NRS scale 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 C and Lactobacillus probiotics for the previous 2 weeks.
• 1. Subjects with any of the following confounding conditions: bladder stones, lower ureteric stones, vaginal candidiasis, urethral diverticulum, urinary retention (≥ 300 mL), overactive bladder (ie, urinary urgency secondary to urinary incontinence), or any other condition/disease, which, in the opinion of the investigator, could compromise patient safety or confound the collection or interpretation of study results.
• 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 without bladder removal or bladder augmentation.
• 4. Subjects with a history of bladder cystoscopy only within 1 month or cystoscopy with bladder biopsy, hydrodistension, fulguration or triamcinolone injection or treatment of 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's disease, 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 screening that has not been evaluated.
• 9. Subjects who have had major surgery within the past 3 months or has surgery planned during the study period
• 10. Subjects with a history of alcohol and/or drug abuse that in the investigator's opinion 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 in the prior 12 months
• 13. Subjects with indwelling ureteral stents
• 14. Subjects that have received a bladder instillation within the last 4 weeks