norman zinner md ms facs founder and medical director western clinical research torrance california n.
Download
Skip this Video
Download Presentation
Norman Zinner, MD, MS, FACS Founder and Medical Director Western Clinical Research Torrance, California

Loading in 2 Seconds...

play fullscreen
1 / 23

Norman Zinner, MD, MS, FACS Founder and Medical Director Western Clinical Research Torrance, California - PowerPoint PPT Presentation


  • 154 Views
  • Uploaded on

Norman Zinner, MD, MS, FACS Founder and Medical Director Western Clinical Research Torrance, California. Measuring Urgency – End Points in Overactive Bladder (OAB) Syndrome.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Norman Zinner, MD, MS, FACS Founder and Medical Director Western Clinical Research Torrance, California' - lacy


Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
norman zinner md ms facs founder and medical director western clinical research torrance california

Norman Zinner, MD, MS, FACSFounder and Medical DirectorWestern Clinical ResearchTorrance, California

Measuring Urgency – End Points in Overactive Bladder (OAB) Syndrome

oab a symptom syndrome
OAB is defined as “urgency with or without urge incontinence, usually with frequency and nocturia” where urgency is defined as “ the complaint of a sudden compelling desire to pass urine that is difficult to defer”OAB: A Symptom Syndrome

Urgency, “the complaint of a sudden compelling desire to pass urine that is difficult to defer”

potential urgency pathways
Potential Urgency Pathways

Brain

Spinal Tract Neurons

PMC

afferent nerve excitability

central sensory processing

myogenic process

urothelial-afferent interactions

Spinal Efferents

Ganglia

Bladder

Ach

PMC = pontine micturition center.

how to measure urgency in oab
How to Measure Urgency in OAB
  • Objective measurement of urgency is difficult
    • No previously validated scales
    • Verysubjective symptom
      • Metrics
        • Likert
        • Pain Scales

Standardized/validated scales are needed!

De Jong PR, et al. Annual Meeting of the International Continence Society, 2004.

measuring urgency
Measuring Urgency
  • A validated patient-reported measure of the event-specific severity of urinary urgency in the context of clinical trials

Indevus Urgency Severity Scale (IUSS)

Nixon A, et al. J Urol. 2005;174:604-607.

indevus urgency severity scale iuss
Indevus Urgency Severity Scale: IUSS

4-point scale

0

1

2

3

Nixon A, et al. J Urol. 2005;174:604-607.

measuring urgency iuss cont d
Measuring Urgency: IUSS (Cont’d)
  • Validation with
    • Urinary frequency
    • Urinary incontinence (UI) episodes
    • Volume voided
    • Incontinence Impact Questionnaire (IIQ) scores
    • Construct/content validity
    • Test/retest
    • Responsiveness to change

Nixon A, et al. J Urol. 2005;174:604-607.

using the iuss to evaluate urgency severity
Using the IUSS to Evaluate Urgency Severity

Study 2

Study 1

1

4

12

1

4

12

*

*

Mean Change in Urgency Severity Score/Void

***

***

***

***

Weeks

Weeks

Placebo

*P0.01.***P0.0001.

Trospium

For both studies, urgency severity scores at baseline were 1.8 for both placebo and trospium chloride.

Zinner NR. Expert Opin Pharmacother. 2005;6:1409-1420.

changes from baseline in iuss by baseline quartiles
Changes From Baseline in IUSS by Baseline Quartiles

12 Weeks

0.1

0

*

-0.1

Mean Change From Baseline in IUSS at Week 12

*

-0.2

Placebo

Trospium

*

-0.3

*

-0.4

0 to 1.435

>1.435 to 1.522

>1.522 to 2.127

>2.127 to 3.0

Baseline IUSS Quartile Ranges

*P<0.05.

Sand P, Zinner N. Annual Meeting of the International Continence Society, 2005.

changes from baseline in percentage of voids by iuss categories
Changes From Baseline in Percentage of Voids by IUSS Categories

12 Weeks

40

30

20

10

Change From Baseline to Week 12 in Percentage of Voids

0

-10

20

Placebo

-30

Trospium

-40

None

Mild

Moderate

Severe

IUSS Urgency Severity Category

Sand P, Zinner N. Annual Meeting of the International Continence Society, 2005.

iuss limitations
IUSS Limitations
  • Urgency Severity Score may not fully describe the impact of thepatient urgency symptom
  • Individual learned or instructed behaviors decrease average urgency severity
the oab symptom composite score
The OAB Symptom Composite Score
  • Since no single parameter has been shown to determine the total impact of OAB on a patient, a scale (OAB-SCS) was developed to evaluate the sum of the major OAB symptoms
  • In this way, the suite of symptoms can be looked at together to more fully understand patient experience with treatment/treatment efficacy

Zinner N, et al. J Urol. 2005;173:1639.

oab scs components
OAB-SCS Components
  • Comprises common patient-reported diary data, including
    • 24-hour voiding frequency
    • Urgency severity (IUSS) associated with each toilet void
    • Frequency of UUI episodes
  • Examines the suite of symptoms together to more fully understand patient experience with treatment/treatment efficacy

UUI = urgency urinary incontinence.

Zinner N, et al. J Urol. 2005;173:1639.

oab symptom composite score
OAB Symptom Composite Score
  • 2 multicenter, randomized, controlled trials
    • Trospium chloride vs placebo
    • N=1157 (n=581 placebo; n=576 trospium)
    • Overactive bladder inclusion criteria
    • Patient diary data included as component (IUSS)

Zinner N, et al. J Urol. 2005;173:1639.

iuss values per toilet void and corresponding oab scs points per toilet void or uui
IUSS Values per Toilet Void and Corresponding OAB-SCS Points per Toilet Void or UUI

Zinner N, et al. J Urol. 2005;173:1639.

oab scs total for patient reported toilet voids and uui events during 1 day of diary collection
OAB-SCS Total for Patient-Reported Toilet Voids and UUI Events During 1 Day of Diary Collection

Zinner N, et al. J Urol. 2005;173:1639.

baseline distribution of oab scs values
Baseline Distribution of OAB-SCS Values

30

25

20

Percentage of Patients

15

10

5

0

0 20 40 60 80 100 120

Baseline OAB-SCS

Zinner N, et al. J Urol. 2005;173:1639.

oab scs tertiles and corresponding oab symptom profile at baseline
OAB-SCS Tertiles and Corresponding OAB Symptom Profile at Baseline

Median OAB-SCS Tertile

Zinner N, et al. J Urol. 2005;173:1639.

median change from baseline in oab scs
Median Change From Baseline in OAB-SCS

Week 1

Week 4

Week 12

Time Point

0

-2

n=577

Placebo

-4

n=544

Trospium

n=573***

Median Change From Baseline

n=509

-6

-8

n=545***

n=500***

-10

***P-value <0.0001 for treatment comparability from ANOVA.

Zinner N, et al. J Urol. 2005;173:1639.

oab symptom composite score1
OAB Symptom Composite Score
  • Provides a single quantifiable value to the overall number and severity of OAB symptoms
  • Accounts for the association of void frequency and urgency severity/void
  • Incorporates all incontinence events
  • Enables clinically relevant interpretations of therapeutic efficacy

Zinner N, et al. J Urol. 2005;173:1639.

summary
IUSS: validated urgency measurement scale for evaluation of clinical efficacy

OAB-SCS: clinically, easily interpretable composite score of 3 OAB symptoms

Summary

Additional scales necessary for accurate evaluation of treatment efficacy in OAB

iuss values per toilet void and corresponding oab scs points per toilet void or uui1
IUSS Values per Toilet Void and Corresponding OAB-SCS Points per Toilet Void or UUI

Zinner N et al. J Urol. 2005;173:1639.