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Interstitial CystitisNCT05276466

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

A study testing Polymerase Chain Reaction and Next-Generation DNA Sequencing in people with Interstitial Cystitis and Bladder Pain Syndrome, run by MicroGenDX at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Interstitial Cystitis, Bladder Pain Syndrome
What is being tested?
Polymerase Chain Reaction and Next-Generation DNA Sequencing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesUnited States
Study dates
1 Feb 2022to 15 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

  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.

Exclusion Criteria: Subjects will be excluded from participating in this study if they meet any of the following criteria:

  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

Trial locations and contacts

4 sites in 1 country.

United States4 sites, 3 recruiting

  • Cooper University Health Care

    Camden, New Jersey, 08103

    Bhaven Murji, 856-968-7547, murji-bhaven@cooperhealth.edu

    Lioudmila Lipetskaia, MD

    Recruiting

  • UCLA Center for Women's Pelvic Health

    Los Angeles, California, 90095

    Crystal Cisneros, 833-825-2974, CCisneros@mednet.ucla.edu

    Anne L Ackerman, MD

    Recruiting

  • The University of California San Diego Health

    San Diego, California, 92103

    Trisha Kanie, 619-543-6544, tkanie@health.ucsd.edu

    Jennifer Anger, MD

    Recruiting

  • Wake Forest University Baptist Medical Center Urology

    Winston-Salem, North Carolina, 27103

    Completed

Other trials in United States

About this study

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.

Read the detailed description

This is a 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 patients identified with BPS and/or CCS symptoms. Eligible subjects will undergo a baseline/screening visit at which time the following will be collected: demographics/history, physical examination, Numerical Rating Scale (NRS) pain (average and maximum), Female Genito-Urinary Pain Index (F-GUPI), Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index (ICSI/ICPI), Acute Cystitis Symptom Score (ACSS), and the Short Form -12.v2 Quality of Life Questionnaire (SF-12). MSU and catheterized urine specimens will be collected for urinalysis (UA), standard culture, and PCR/NGS. Subjects will be stratified based on BPS (NIDDK MAPP criteria) or CCS (based on ACSS criteria) symptoms.

Uropathogens detected on PCR/NGS catheterized specimens will be treated with 10 days of PCR/NGS directed antibiotic therapy which will be recommended by a centralized infectious disease consultant. If there are no uropathogenic bacteria in the catheter specimen, the MSU specimen will be used if positive. Prescribing physicians will adjust those recommendations (choice of antibiotic as well as duration of therapy) based on individual patient's history of antibiotic therapy and known allergies and sensitivities. Subjects with negative PCR/NGS findings for potential uropathogens will be treated with 10 days of empiric antibiotic therapy chosen by the investigator from this list b: 1. Trimethoprim sulfamethoxazole, 2. Macrocrystalline nitrofurantoin, 3. Fosfomycin, and 4. Investigator choice. More than one antibiotic may be prescribed if two or more uropathogens are identified. At the discretion of the treating physician with the consent and shared decision making with the patient, a decision may be made to continue antibiotic therapy beyond 10 days if the patient subjectively believes she is responding. In this study, all subjects will be offered antibiotic therapy, either NGS directed or empiric. Fourteen days after beginning antibiotics, the Subjective Global Assessment (SGA), compliance and safety will be determined via phone call. A clinic visit will be scheduled for 14 days after finishing antibiotics for repeat evaluation of symptoms (NRS pain, F-GUPI, ICSI/ICPI, ACSS, SF-12, SGA) and safety. A MSU urine specimen will be collected from all subjects and submitted for PCR/NGS analysis. Subjects who were PCR/NGS negative and failed empiric therapy will be notified that they likely do not have an infection. Primary analyses will be based on the responder rate (SGA responder rate will be the primary efficacy parameter), symptom change based on the other questionnaires, and safety in BPS/CCS subjects treated with PCR/NGS as well as those treated with empiric therapy. A 40% SGA responder rate, where a responder is defined as markedly or moderately improved on the GRA 7-point scale, will be considered a clinically significant impact. A follow-up visit 4 weeks later will collect similar data as collected at the efficacy visit.

Being tested
Polymerase Chain Reaction and Next-Generation DNA Sequencing
Keywords
BPS, IC, NGS, PCR
Medical subject headings
Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polymerase Chain Reaction and Next-Generation DNA SequencingDiagnostic 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.

Study groups in NCT05276466
Study groupRoleWhat they receive
Single armOtherAll subject's samples will undergo the same diagnostic test utilizing Polymerase Chain Reaction and Next-Generation DNA Sequencing
Receives: Diagnostic Test: Polymerase Chain Reaction and Next-Generation DNA Sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (4)

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

    Determine the safety of employing a PCR/NGS directed antimicrobial therapy strategy in female subjects with BPS and CCS.

    Measured: 1 year

  2. concordance

    Evaluate concordance of culture results with PCR/NGS findings in this population of women.

    Measured: 1 year

  3. Type of sample comparison

    Compare the microbiome of midstream and catheterized urine specimens of symptomatic female subjects with BPS and CCS.

    Measured: 1 year

  4. Stratification comparison

    Compare urinary microbiome of symptomatic population of women stratified based on PCR/NGS positive and PCR/NGS negative subgroups, positive/negative cultures, and BPS and CCS.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start1 Feb 2022
  3. Primary completion15 Nov 2023 (estimated)
  4. Study completion15 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Single group assignment
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05276466
Sponsor's protocol ID
MDX-001
Status last verified
Mar 2023
First submitted
4 Nov 2021
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently no plan to share individual data to other researchers.

Publications

  • 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.

    PubMed 21497847

  • 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.

    PubMed 21920661

  • 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.

    PubMed 30917614

  • 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.

    PubMed 26410734

  • 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.

    PubMed 33352734

  • 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.

    PubMed 9146003

Questions about this trial

What is this clinical trial studying?

A study testing Polymerase Chain Reaction and Next-Generation DNA Sequencing in people with Interstitial Cystitis and Bladder Pain Syndrome, run by MicroGenDX at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of PCR/NGS directed antimicrobial therapy assessed by the Global Response Assessment (GRA) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05276466, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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