Evaluation of the 2 x 24hour voiding diary

Sandor LOVASZ MD. PhD.Hungary, Semmelweis Medical University, Budapest

ESSIC Annual MeetingPhiladelphia, June 13-15, 2014

THE GAG-LAYER INTEGRITY THE GAG-LAYER INTEGRITY TESTTEST

THE GAG-LAYER INTEGRITY THE GAG-LAYER INTEGRITY TESTTEST

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

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

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 (=> or <30%)

Although theoretically capable of quantitative measurement - clinically rarely used

Daha LK, Riedl CR et al: Eur Urol 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)

Is there a role of concentration of urine?

Can these observations be used for quantitative testing?

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.

Another sample of a 15 day 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

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)

5 healthy volunteers:

Vol. constant

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• Appropriate for long term follow up

Continuous follow up on the website

We are seeking for partners for a prospective, multicenter clinical trial

To collect pre- and post-treatment data of IC/BPS patients andTo statistically prove correlation betweenQuantitatively measurable values ofSymptoms and GAG integrity-test.