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

NCT05276466 | Unknown DMC

• 1 other identifier: MDX-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

BPS; IC; NGS; PCR

Outcome Measures

Primary Outcomes (1)

• Effectiveness of PCR/NGS directed antimicrobial therapy assessed by the Global Response Assessment (GRA)

  GRA is a 7-point descriptive scale in which subjects self-report that degree that their symptoms improved or worsened compared to baseline. The answers available for the subject includes markedly improved, moderately improved, mildly improved, no change, mildly worse, moderately worse, markedly worse. A responder is a subject who reports that compared to baseline their symptoms are moderately or markedly improved. The primary analysis will determine the proportion of subjects who are responders at the efficacy visit.

  1 year

Secondary Outcomes (4)

• Safety of PCR/NGS directed antimicrobial therapy by measuring the incidence of Treatment-Emergent Adverse Events by the SAE questionnaire

  1 year

• concordance

  1 year

• Type of sample comparison

  1 year

• Stratification comparison

  1 year

Study Arms (1)

Single arm

OTHER

All subject's samples will undergo the same diagnostic test utilizing Polymerase Chain Reaction and Next-Generation DNA Sequencing

Diagnostic Test: Polymerase Chain Reaction and Next-Generation DNA Sequencing

Interventions

Polymerase Chain Reaction and Next-Generation DNA Sequencing DIAGNOSTIC_TEST

The qPCR Rapid Screening Panel is a quantitative real-time PCR test for bacteria and fungi. Next-Generation DNA Sequencing is the Comprehensive Sequencing test will detect virtually all microbial organisms and fungal pathogens that may be present in patient specimens.

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroGenDX: lead

Study Sites (4)

UCLA Center for Women's Pelvic Health

Los Angeles, California, 90095, United States

RECRUITING

The University of California San Diego Health

San Diego, California, 92103, United States

RECRUITING

Cooper University Health Care

Camden, New Jersey, 08103, United States

RECRUITING

Wake Forest University Baptist Medical Center Urology

Winston-Salem, North Carolina, 27103, United States

COMPLETED

Related Publications (6)

• Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.

  PMID: 21497847 BACKGROUND

• Giannantoni A, Bini V, Dmochowski R, Hanno P, Nickel JC, Proietti S, Wyndaele JJ. Contemporary management of the painful bladder: a systematic review. Eur Urol. 2012 Jan;61(1):29-53. doi: 10.1016/j.eururo.2011.07.069. Epub 2011 Sep 9.

  PMID: 21920661 BACKGROUND

• Nickel JC, Stephens-Shields AJ, Landis JR, Mullins C, van Bokhoven A, Lucia MS, Henderson JP, Sen B, Krol JE, Ehrlich GD; MAPP Research Network. A Culture-Independent Analysis of the Microbiota of Female Interstitial Cystitis/Bladder Pain Syndrome Participants in the MAPP Research Network. J Clin Med. 2019 Mar 26;8(3):415. doi: 10.3390/jcm8030415.

  PMID: 30917614 BACKGROUND

• Nickel JC, Stephens A, Landis JR, Mullins C, van Bokhoven A, Lucia MS, Ehrlich GD; MAPP Research Network. Assessment of the Lower Urinary Tract Microbiota during Symptom Flare in Women with Urologic Chronic Pelvic Pain Syndrome: A MAPP Network Study. J Urol. 2016 Feb;195(2):356-62. doi: 10.1016/j.juro.2015.09.075. Epub 2015 Sep 26.

  PMID: 26410734 BACKGROUND

• Alidjanov JF, Naber KG, Pilatz A, Wagenlehner FM. Validation of the American English Acute Cystitis Symptom Score. Antibiotics (Basel). 2020 Dec 19;9(12):929. doi: 10.3390/antibiotics9120929.

  PMID: 33352734 BACKGROUND

• O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.

  PMID: 9146003 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: March 11, 2022
• Study Start: February 1, 2022
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)