Microbial Biomarker Testing for Pelvic and Bladder Pain Classification
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Solution Overview
Problem
There is significant symptomatic overlap and misdiagnosis in reproductive-age women with conditions like interstitial cystitis/bladder pain syndrome, chronic pelvic pain, overactive bladder syndrome, and vulvodynia, leading to delayed and inappropriate treatment due to the lack of specific bacterial markers for these conditions.
Innovation Solution
The method involves detecting levels of specific microorganisms such as Lactobacillus iners, E. coli, and other bacteria in urine samples using qPCR or next-generation sequencing, and administering targeted therapies based on the microbial profiles to treat interstitial cystitis, pelvic pain, or bladder pain.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional diagnostic methods are used for pelvic and bladder pain conditions, then treatment can be provided, but misdiagnosis and delayed care occur due to symptomatic overlap
Solution Approach 1:
The patent introduces microbial biomarkers as an intermediary diagnostic tool that bridges the gap between non-specific symptoms and specific diagnoses. By detecting specific bacteria (e.g., E. coli, Lactobacillus species) in urine samples, the test provides objective evidence that mediates between subjective symptom reporting and definitive diagnosis, resolving the contradiction between maintaining diagnostic simplicity and improving accuracy.
Solution Approach 2:
The patent replaces the mechanical/manual diagnostic process (clinical evaluation based on symptom overlap) with a molecular biology-based detection system (qPCR or next-generation sequencing). This substitution eliminates the subjectivity and time-consuming nature of traditional diagnostic methods by using automated genetic analysis to identify pathogenic microorganisms, thereby improving both accuracy and speed.
2Reliability
If no specific testing is performed for pelvic pain conditions, then treatment protocols can be applied, but appropriate care is delayed due to lack of prognostic testing
Solution Approach 1:
The patent implements preliminary diagnostic action by performing microbial biomarker testing before initiating treatment protocols. This preliminary identification of pathogenic microorganisms allows clinicians to select appropriate treatments in advance, avoiding the trial-and-error approach and ensuring that patients receive targeted therapy from the outset, thereby improving treatment appropriateness without delaying care.
3Adaptability or versatility
If traditional broad-spectrum treatments are used for pelvic pain, then all patients can be treated, but treatment efficacy is reduced due to lack of personalized therapy
Solution Approach 1:
The patent applies local quality by tailoring treatment to the specific microbial profile of each patient rather than applying uniform broad-spectrum therapy. By identifying the specific pathogenic microorganism present (e.g., E. coli vs. Lactobacillus species), clinicians can select targeted antibiotics or therapies appropriate to that specific pathogen, thereby improving treatment efficacy through personalized care while maintaining the ability to treat diverse patient populations.
Data Source
AI summary
The invention describes methods for a method of detecting levels of one or more microorganisms, selecting treatment for interstitial cystitis, pelvic pain, bladder pain and myofascial pain and treating interstitial cystitis, pelvic pain, bladder pain and myofascial pain. The invention also describes detecting bacterial phenotype and kits.