Meeting on Measurement of Urinary Symptoms (MOMUS)

Event Details

Background

Symptoms of lower urinary tract dysfunction (LUTD) are common both in men and women. Both incidence and prevalence rates increase with age; consequently, treatment costs pose a major financial challenge to the Nation. The American Urological Association (AUA) symptom score, which was initially intended for benign prostatic hyperplasia (BPH) patients, is widely used in clinical practice. In addition, it is often used as an endpoint in clinical trials to assess symptom-based clinical improvement in benign lower urinary tract disease. Using the current AUA symptom score may not only be misleading clinically and correlate weakly with patient satisfaction, but also can be scientifically invalid and impede scientific progress. Thus, a better measurement tool that focuses on patient reported outcomes (PRO) is essential to quantify early, late, transient, and persistent symptoms of LUTD both in men and women.AnujTesting

The goal of this meeting is to increase discussion about this topic among various populations with different expertise: urologists, patients, other clinicians, researchers, industry, advocacy groups, and various government agencies such as the U.S. Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality.

Meeting Objectives

• Discuss the uses and shortcomings of current symptom-based instruments in research of LUTD.
• Disseminate state-of-the-art methodology to improve patient reported outcomes (PRO) of LUTD symptoms.
• Discuss the validation and qualification process of new measurement tools, and patient phenotyping.
• Align the new LUTD symptom measurement tool among involved parties.

Planning Committee

Michael Albo
Lisa Begg
Paul Eggers
Ziya Kirkali
John Kusek
Mark Litwin
Kevin McVary
Robert Star
John Wei
Kevin Weinfurt
Yining Xie

Agenda

November 14, 2011

7:30 - 8:30 a.m.

Registration

8:30 - 8:45 a.m.

Introduction and Opening Remarks
Griffin Rodgers, Janine Clayton, and Ziya Kirkali

I. Public Health Importance of Measuring Symptomatic Lower Urinary Tract Dysfunction (LUTD)

Moderator: Kevin McVary

8:45 - 9:00 a.m.

We Are All Happy, Why Bother?
Paul Abrams

9:00 - 9:15 a.m.

Public Health Importance of Measuring LUTD Symptoms
Mark Litwin

9:15 - 9:30 a.m.

Can Intervention for Symptoms Always Provide Patient Goal Achievement?
William Lawrence

9:30 - 9:45 a.m.

Measurement of PRO - The PROMIS initiative
William Riley

9:45 - 10:15 a.m.

PRO in the Evaluation of Medical Productsfor Regulatory Approval
Laurie Burke

10:15 - 10:30 a.m.

Discussion

10:30 - 10:45 a.m.

Break

10:45 - 10:55 a.m.

What I Expected and Found After Prostatectomy
Robert Wedgworth

10:55 - 11:05 a.m.

Do Drugs Really Do it for Me?
Patient

11:05 - 11:15 a.m.

Am I Aged Enough to Develop Urinary Symptoms? Wait; and Pain?
Tom Colclasure

11:15 - 11:25 a.m.

I Accept Urinating Frequently, but This Pain Is Wearing Me Out
Laura Santurri

11:25 - 11:35 a.m.

Is it My Destiny to Leak?
Patient

11:35 - 11:45 a.m.

Incontinence: From beginning to end?
Harry "Doug" Swank

11:45 a.m. - 12:00 p.m.

Discussion

12:00 - 1:00 p.m.

Lunch

III. What Is Currently Missing in the Measurement of LUTD Symptoms?

Moderator: Gopal Badlani

1:00 - 1:15 p.m.

Current Instruments to Measure Symptomatic LUTD for Diagnostic, Statistic, and Outcome Purposes
Johannes Vieweg

1:15 - 1:30 p.m.

Is the AUA SS Still the Best Instrument for Clinical Research?
Claus Roehrborn

1:30 - 1:45 p.m.

How Do We Measure Incontinence?
Marcus Drake

1:45 - 2:00 p.m.

What Domains Are Missing in AUA SS for Clinical Care?
Michael Albo

2:00 - 2:15 p.m.

Bother/Adaptation/Exacerbation of LUTD Symptoms
William Steers

2:15 - 2:30 p.m.

Can a Symptom Measurement Tool Tell Us About the Various Contributing Factors to LUTD?
John Wei

2:30 - 2:45 p.m.

How Is Post-prostatectomy Incontinence Measured?
Jerry Blaivas

2:45 - 3:00 p.m.

Discussion

3:00 - 3:15 p.m.

Break

3:15 - 3:30 p.m.

How Do We Measure Symptoms and Flares In SLE?
Rosalind Ramsey-Goldman

3:30 - 3:45 p.m.

What Tools Are Available for Symptom Measurement in IBS?
Lin Chang

3:45 - 4:00 p.m.

Symptom Measurement in FM/CFS
Fred Friedberg

4:00 - 4:15 p.m.

UCPPS, Measuring Pain, and Flares
Quentin Clemens

4:15 - 4:30 p.m.

Discussion

V. Phenotypes, Clinical Conditions, and Impact on Measurement

Moderator: Michael Albo

4:30 - 4:45 p.m.

Healthy Aging. What Is the Impact of LUTD?
Tomas Griebling

4:45 - 5:00 p.m.

What Did We Learn From MTOPS?
Kevin McVary

5:00 - 5:15 p.m.

Can Symptoms Be Predictive of Progression and Response to Therapy?
Steven Jacobsen

5:15 - 5:30 p.m.

Symptomatic LUTD, ED, and Metabolic Syndrome: What Is the Relevance?
Aruna Sarma

5:30 - 5:45 p.m.

DM and LUTD Symptoms
Firouz Daneshgari

5:45 - 6:00 p.m.

How to Better Phenotype Patients With Symptomatic LUTD
William Steers

6:00 - 6:15 p.m.

Discussion

6:15 p.m.

Adjournment

7:30 p.m.

Dinner

November 15, 2011

VI. Better Understanding of the Symptomatic LUTD Patient: The Future

Moderator: Kevin Weinfurt

8:30 - 8:45 a.m.

What Measures Are Needed and for What Purposes?
Mathew Barber

8:45 - 9:00 a.m.

Should Symptoms of LUTD in Men be Measured Differently in Studies Addressing Modifiable Risk Factors?
Elizabeth Platz

9:00 - 9:15 a.m.

Experience From Cancer Outcome Measures
Claire Snyder

9:15 - 9:30 a.m.

The PROMIS Experience
Kevin Weinfurt

9:30 - 9:45 a.m.

Emerging Technologies in the Measurement of PRO
Jammie Griffith

9:45 - 10:00 a.m.

How Best to Validate a Symptom Measurement Tool for LUTD?
Stephen Van Den Eeden

10:00 - 10:15 a.m.

New and Innovative Phenotyping Methods
Kevin McVary

10:15 - 10:30 a.m.

Barriers to Moving Forward
John Wei

10:30 - 10:45 a.m.

Discussion

10:45 - 11:00 a.m.

Break

11:00 a.m. - 12:00 p.m.

Breakout Sessions

1. Leaders: Marcus Drake and Johannes Vieweg
   What Is Missing in Current Measurement Tools for Male LUTD?
2. Leaders: Michael Albo and Lisa Begg
   What Is Missing in Current Measurement Tools for Female LUTD?
3. Leaders: Kevin Weinfurt and Stephen Van Den Eeden
   How to Validate the New Measurement Instrument
4. Leaders: John Wei and Kevin McVary
   How to Phenotype the Patients with Symptomatic LUTD

12:00 - 12:40 p.m.

Reports of the Breakout Session Leaders

12:40 - 1:00 p.m.

Wrap-up
Robert Star

1:00 p.m.

Adjournment