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

About

Brief Summary

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.

Primary Purpose

Diagnostic

Study Type

Interventional

Phase

N/A

Eligibility

Gender

Female

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

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

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Study Stats

Protocol No.

21-001412