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THE GAG-LAYER INTEGRITY TEST. Evaluation of the 2 x 24hour voiding diary. THE Concept of and first experiences with a new, non-invasive tool for diagnosis and follow up of IC/BPS patients. Sandor LOVASZ MD. PhD. Hungary, Semmelweis Medical University, Budapest. ESSIC Annual Meeting
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THE GAG-LAYER INTEGRITY TEST Evaluation of the 2 x 24hour voidingdiary THE Concept of and first experiences with a new, non-invasive tool for diagnosis and follow up of IC/BPS patients Sandor LOVASZ MD. PhD. Hungary, Semmelweis Medical University, Budapest ESSIC Annual Meeting Philadelphia, June 13-15, 2014
Pathogenesis of BPS/IC: Abnormal epithelial permeability, epithelial leak, increased potassium absorption… Corrupted GAG layer integrity /insufficiency Emerging need of objective and quantitative testing of GAG layer integrity(uncertain and difficult diagnosis) A noninvasivediagnostictoolfor BPS/IC Parsons CL.: J Urol, 1998
Potassium sensitivity test (PST) - Parsons test Sensitivity – 69,5% Specificity – 50% (Chambers GK et al: J Urol 1999) Invasive (catheterization, bladder filling twice, painful, non-quantitative: yes or no) Absence of potassium sensitivity in normal controls Not used as a routine clinical test in monitoring of BPS/IC treatment efficacy. A noninvasivediagnostictoolfor BPS/IC Parsons CL.: Urology. 2001
Modified potassium sensitivity-test (0,2M KCl) Comparing C(max) usingSaline vs. Potassium solution Painless examination yet invasive and time consuming (catheterization + repeated cystometry) Cut off value at 30% growth Non-quantitative (=> or <30%) Although theoretically capable of quantitative measurement - clinically rarely used A noninvasivediagnostictoolfor BPS/IC Daha LK, Riedl CR et al: EurUrol 2005
Our observation is based on anamnestic data of 106 BPS/IC patients: Symptoms usually worsen in summer period Increased liquid consumption leads to remarkably reduced symptoms (pain, urgency) A noninvasivediagnostictoolfor BPS/IC Is there a role of concentration of urine? Canthese observationsbe usedfor quantitative testing?
We asked patients to make a voiding diary by recording total urine volume and averageurine portion • One patient recorded these data over 14 consecutive days from misunderstanding. A noninvasivediagnostictoolfor BPS/IC
A noninvasivediagnostictoolfor BPS/IC Another sample of a 15 day voiding diary
Patients were asked to calculate and record • Average daily urine portion • 24hours full urine volume • Throughout 2 consecutivedays • Day 1 - max 800ml drinking (max. concentrated) • Day 2 - min 3000ml fluidintake (max. diluted) • The growth of meandailyurineportionwasobserved A noninvasivediagnostictoolfor BPS/IC The 2 x 24 hour voiding diary
Our hypotheses (based on these observations) There is a linear correlation between total urine volume (concentration of urine) and average portion The rate of change in average portion corresponds to severity of symptoms in IC/PPS Average urine portion is constant in healthy people, independently from urine volume (concentration) A noninvasive diagnostic tool for BPS/IC 5 healthy volunteers: Vol. constant DVol. : 20-50% DVol. : 100-300%
Continuous follow up on the website www.bladderpain.eu
Continuous follow up on the website
Continuous follow up on the website
Continuous follow up on the website
Continuous follow up on the website
Continuous follow up on the website Impressive correlation between - IC symptoms - Changes of mean urine portions • By proving this correlation we could get a test for GAG layer integrity • Noninvasive • Painless • Quantitative • Not bound to the presence of investigator • Suitable for diagnostic purposes • Appropriatefor long term follow up
A noninvasivediagnostictoolfor BPS/IC We are seeking for partners for a prospective, multicenter clinical trial To collect pre- and post-treatment data of IC/BPS patients and To statistically prove correlation between Quantitatively measurable values of Symptoms and GAG integrity-test.