Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Techno… (NCT05276466) | Clinical Trial Compass
UnknownNot Applicable
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
United States100 participantsStarted 2022-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness of PCR/NGS directed antimicrobial therapy assessed by the Global Response Assessment (GRA)
. 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 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.