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Meeting on Measurement of Urinary Symptoms (MOMUS)

Meeting on Measurement of Urinary Symptoms (MOMUS) - November 14–15, 2011

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Event Details

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.

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 (malbo@mail.ucsd.edu)
Lisa Begg (beggl@od.nih.gov)
Paul Eggers (paul.eggers@nih.gov)
Ziya Kirkali (ziya.kirkali@nih.gov)
John Kusek (john.kusek@nih.gov)
Mark Litwin (mlitwin@mednet.ucla.edu)
Kevin McVary (k-mcvary@northwestern.edu)
Robert Star (robert.star@nih.gov)
John Wei (jtwei@med.umich.edu)
Kevin Weinfurt (kevin.weinfurt@duke.edu)
Yining Xie (yining.xie@nih.gov)

Agenda

Monday, 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 Products for Regulatory Approval
Laurie Burke
10:15 – 10:30 a.m. Discussion
10:30 – 10:45 a.m. Break
   
II. Patient-focused Approach to an Invisible Condition
Moderator: Lisa Begg
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
   
IV. How Are PROs Measured in Other Conditions?
Moderator: John Wei
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
   
Tuesday, 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. Break-out 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

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Contact

Workshop Organizers:
Dr. Ziya Kirkali, NIDDK, NIH
ziya.kirkali@nih.gov

Dr. Yining Xie, NIDDK, NIH
yining.xie@nih.gov

For registration information, contact:
Ms. Mary Compton, The Scientific Consulting Group, Inc.
mcompton@scgcorp.com

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HOTEL INFO

Bethesda Marriott Hotel
5151 Pooks Hill Road
Bethesda, MD 20814
Phone: (301) 897-9400 OR (800) 266-9432
Website: http://www.bethesdamarriott.com Exit Disclaimer
(More hotel information can be obtained from this website.)

A block of sleeping rooms has been reserved at the Bethesda Marriott (5151 Pooks Hill Road, Bethesda) for arrival on Sunday, November 13, 2011, and departure on Tuesday, November 15, 2011. To make a reservation, call (800) 266-9432 and mention the Room Block (“MOMUS”) to obtain the government rate. You may also make your reservation online: https://resweb.passkey.com/go/momusmtgExit Disclaimer

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From Points North and East:

Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Points North and West:
Take I-270 South to I-495 East (Capital Beltway) toward Washington, DC. Stay in one of the three left lanes. Follow signs for Route 355 South, a left-lane exit, onto Wisconsin Avenue. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Points South:
Take I-95 North to I-495 (Capital Beltway) toward Tyson's Corner/Rockville. Follow I-495 for 20 miles. Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Take the Route 195 connector to I-95 South. Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Washington Dulles International Airport (IAD):
Take the Dulles Access Road for approximately 13 miles to Exit 18. Move to the right on the Dulles Toll Road (Route 267) and take Exit 18. Stay left on the ramp for Bethesda/Baltimore, and proceed toward Bethesda (I-495). Continue approximately 9 miles on I-495. Stay on I-495 at the I-495/I-270 split (bear right). Take Exit 34 (Wisconsin Avenue South/Route 355) toward Bethesda. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Ronald Reagan Washington National Airport (DCA):
Take the George Washington Parkway North for 12 miles to I-495 toward Maryland (Capital Beltway). Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

Parking
Parking on the NIH campus is limited and is $12 per day in the visitor lots.

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Page last updated: October 31, 2011

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