THE Concept of and first experiences with a new, non-invasive tool for diagnosis and follow up of IC/BPS patients

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THE Concept of and first experiences with a new,
non-invasive tool for diagnosis and follow up of
IC/BPS patients

• Evaluation of the 2 x 24hour voiding diary

THE GAG-LAYER INTEGRITY TEST
Sandor LOVASZ MD. PhD. Hungary, Semmelweis
Medical University, Budapest
ESSIC Annual Meeting Philadelphia, June 13-15,
2014
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A noninvasive diagnostic tool for BPS/IC

• 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)

Parsons CL. J Urol, 1998
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A noninvasive diagnostic tool for BPS/IC

• 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.

Parsons CL. Urology. 2001
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A noninvasive diagnostic tool for BPS/IC

• Modified potassium sensitivity-test (0,2M KCl)
• Comparing C (max) using Saline vs. Potassium
  solution
• Painless examination yet invasive and time
  consuming
• (catheterization repeated cystometry)
• Cut off value at 30 growth
• Non-quantitative (gt or lt30)
• Although theoretically capable of quantitative
  measurement - clinically rarely used

Daha LK, Riedl CR et al Eur Urol 2005
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A noninvasive diagnostic tool for BPS/IC

• 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)

Is there a role of concentration of urine?
Can these observations be used for quantitative
testing?
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A noninvasive diagnostic tool for BPS/IC

• We asked patients to make a voiding diary by
  recording total urine volume and average urine
  portion
• One patient recorded these data over 14
  consecutive days from misunderstanding.

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A noninvasive diagnostic tool for BPS/IC
Another sample of a 15 day voiding diary
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A noninvasive diagnostic tool for BPS/IC
The 2 x 24 hour voiding diary

• Patients were asked to calculate and record
• Average daily urine portion
• 24 hours full urine volume
• Throughout 2 consecutive days
• Day 1 - max 800ml drinking (max. concentrated)
• Day 2 - min 3000ml fluid intake (max. diluted)
• The growth of mean daily urine portion was
  observed

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A noninvasive diagnostic tool for BPS/IC
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A noninvasive diagnostic tool for BPS/IC
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A noninvasive diagnostic tool for BPS/IC
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A noninvasive diagnostic tool for BPS/IC
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A non-invasive diagnostic tool for BPS/IC
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A noninvasive diagnostic tool for BPS/IC
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A noninvasive diagnostic tool for BPS/IC

• 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)

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Continuous follow up on the website
www.bladderpain.eu
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Continuous follow up on the website
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Continuous follow up on the website
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Continuous follow up on the website
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Continuous follow up on the website
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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
• Appropriate for long term follow up

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A noninvasive diagnostic tool for 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.