U.S. Department of Health and Human Services

Meeting on Measurement of Urinary Symptoms (MOMUS)

11/14/2011 7:00 AM
11/15/2011 7:00 AM
Yes
No
​​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
Bethesda
 
Natcher Conference Center

Event Details

MISSION STATEMENT

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)
Robert Star (robert.star@nih.gov)
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 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

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

Directions/Travel

HOTEL INFO

Bethesda Marriott Hotel
5151 Pooks Hill Road
Bethesda, MD 20814
Phone: (301) 897-9400 OR (800) 266-9432
(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/momusmtg
 
Please note that reservations must be cancelled no later than 24 hours prior to the scheduled arrival date or you will be charged for 1 night's room and tax. Check-in time is 4:00 p.m., and check-out time is 12:00 p.m.

HOTEL SHUTTLE

There is a free shuttle to the NIH Campus that departs from the hotel every half an hour.

LOCATION INFO

National Institutes of Health (NIH) Visitor Information
The Natcher Auditorium is located on the NIH Campus in Building 45. For a map, general information, and directions to and around the NIH Campus, visit http://parking.nih.gov/visitor_access_map.htm.

NIH Security

The NIH, like all federal government facilities, has instituted security measures to ensure the safety of NIH employees, patients, and visitors. The national threat advisory level is determined by the Department of Homeland Security (http://www.whitehouse.gov/homeland/).

Perimeter Security

All visitor vehicles, including taxicabs, hotel and airport shuttles, delivery trucks, and vans will be inspected before being allowed on campus. Visitors will be asked to show one (1) form of identification (a government-issued photo ID: driver's license, passport, green card, etc.) and to state the purpose of their visit. Be sure to allow at least 15-20 minutes for this vehicle inspection procedure.

Building Security

Due to the checking of IDs at the perimeter, employees and visitors will not be required to show their ID again to gain access to the majority of buildings on the NIH Campus during the normal business day.
 
Employees and visitors should continue to wear their identification prominently at all times while on campus.

Weekday Campus Access

Visitors, including meeting attendees, patients, contractors, vendors, and delivery persons: All visitors must use the following entrances (see the Visitor Map at http://parking.nih.gov/visitor_access_map.htm):
  • Rockville Pike at South Drive (Metro): Regular weekday schedule: Open 24 hours for inbound and outbound traffic.
  • Old Georgetown Road at Center Drive: This entrance is primarily for commercial vehicles and visitors.
Regular weekday schedule:
5:00 a.m. to 2:00 p.m. - Inbound traffic only
2:00 p.m. to 7:00 p.m. - Inbound and outbound traffic
7:00 p.m. to 5:00 a.m. - Closed to all traffic

Driving Directions to NIH

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.

Minutes

​Minutes are currently unavailable.

Attendees

​​Attendees are currently unavailable.

Abstracts

​​Abstracts are currently unavailable.

Location

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  • Building 45, NIH Campus
  • MD 20892
Webinar

Contacts

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​​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