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
Real-world clinical practice multicenter study to determine the clinical implications of employing PCR/NGS technology to identify and treat potential urinary pathogens in female participants identified with bladder pain and/or cystitis-like symptoms.
Inclusion Criteria: Subjects may be included in the study if they have bladder and/or
urethral pain and lower urinary tract storage symptoms and only if they meet all of the following criteria at screening/baseline.
- Subjects are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol.
- 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)
- 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.
- Subjects who have experienced a minimum of 3 months of continuous symptoms
- Subjects who have a minimum average daily bladder pain score of ≥ 3 on a 0-10 NRS scale in the past 3 months
- Subjects with no antibiotic therapy for the previous 2 weeks
- Subjects with no UTI supplements including cranberry, d-mannose, high dose vitamin C and Lactobacillus probiotics for the previous 2 weeks.
Exclusion Criteria: Subjects will be excluded from participating in this study if they meet
any of the following criteria:
- 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.
- Subjects who are pregnant or planning a pregnancy during the study period
- Subjects with a history of previous urinary diversion procedure with or without bladder removal or bladder augmentation.
- 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.
- Subjects undergoing active treatment for cancer - urologic (eg bladder) or other - with surgery, radiation or chemotherapy within previous 8 weeks of screening.
- Subjects with a neurogenic bladder (due to spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, or diabetic cystopathy).
- Subjects with genital herpes active within 3 months prior to screening.
- Subjects with a history of gross (visible) hematuria within 1 year prior to screening that has not been evaluated.
- Subjects who have had major surgery within the past 3 months or has surgery planned during the study period
- 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.
- Subjects catheterized in the past month
- Subjects that have received antibiotic treatment based on MicroGenDX's NGS results in the prior 12 months
- Subjects with indwelling ureteral stents
- Subjects that have received a bladder instillation within the last 4 weeks