RECRUITING

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

Conditions

Interstitial Cystitis Bladder Pain Syndrome BPS IC NGS PCR

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-01

Study Completion:2023-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05276466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

UCLA Center for Women's Pelvic Health

Los Angeles, California, 90095

United States

The University of California San Diego Health

San Diego, California, 92103

United States

Cooper University Health Care

Camden, New Jersey, 08103

United States

Wake Forest University Baptist Medical Center Urology

Winston-Salem, North Carolina, 27103

United States

Collaborators and Investigators

Sponsor: MicroGenDX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2023-12-15

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2023-12-15

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Interstitial Cystitis
Bladder Pain Syndrome